Prosthetic valve with separably-deployable valve body and tissue anchors

ABSTRACT

Embodiments of the present disclosure are directed to prosthetic valves and methods of use thereof. In one implementation, a method of implanting a prosthetic valve within a native mitral valve may be provided. The method may include delivering the prosthetic valve into a heart chamber. The prosthetic valve may be constrained in a contracted delivery configuration. The prosthetic valve may include an annular valve body with a plurality of ventricular anchors and a plurality of atrial anchors attached thereto. The method may also include unconstraining the plurality of ventricular anchors and the plurality of atrial anchors while maintaining the valve body in the contracted delivery configuration. The method may also include unconstraining the valve body from the contracted delivery configuration while the unconstrained atrial anchors are positioned within an atrium and while the unconstrained ventricular anchors are positioned within a ventricle.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/682,789, filed Aug. 22, 2017, now pending, which is a continuation ofU.S. patent application Ser. No. 15/541,783, filed Jul. 6, 2017, whichissued as U.S. Pat. No. 9,974,651 on May 22, 2018, which is a U.S.national stage entry under 35 U.S.C. § 371 of International ApplicationNo. PCT/IL2016/050125, filed Feb. 3, 2016, which claims priority fromU.S. Provisional Patent Application No. 62/112,343, filed Feb. 5, 2015,all of which are hereby incorporated by reference in their entirety.This application also claims priority from U.S. Provisional PatentApplication No. 62/560,384, filed Sep. 19, 2017, which is herebyincorporated by reference in its entirety.

FIELD OF THE INVENTION

Some embodiments of the present disclosure relate in general to valvereplacement. More specifically, some embodiments of the presentdisclosure relate to prosthetic valves for replacement of a cardiacvalve.

BACKGROUND

Ischemic heart disease causes regurgitation of a heart valve by thecombination of ischemic dysfunction of the papillary muscles, and thedilatation of the ventricle that is present in ischemic heart disease,with the subsequent displacement of the papillary muscles and thedilatation of the valve annulus.

Dilatation of the annulus of the valve prevents the valve leaflets fromfully coapting when the valve is closed. Regurgitation of blood from theventricle into the atrium results in increased total stroke volume anddecreased cardiac output, and ultimate weakening of the ventriclesecondary to a volume overload and a pressure overload of the atrium.

SUMMARY OF THE INVENTION

For some embodiments of the present disclosure, an implant is providedhaving a tubular portion, an upstream support portion and one or moreflanges. The implant is percutaneously deliverable to a native heartvalve in a compressed state, and is expandable at the native valve. Theimplant and its delivery system facilitate causing the upstream supportportion and the flanges to protrude radially outward from the tubularportion without expanding the tubular portion. Expansion of the tubularportion brings the upstream support portion and the flanges closertogether, for securing the implant at the native valve by sandwichingtissue of the native valve between the upstream support portion and theflanges.

In accordance with an embodiment of the present disclosure, an apparatusis provided for use with a native valve that is disposed between anatrium and a ventricle of a heart of a subject, the apparatus includinga valve frame, including a tubular portion that circumscribes alongitudinal axis of the valve frame so as to define a lumen along theaxis, the tubular portion defining a plurality of valve-frame couplingelements disposed circumferentially around the longitudinal axis; aplurality of prosthetic leaflets, coupled to the frame, disposed withinthe lumen, and arranged to provide unidirectional flow of blood from anupstream end of the lumen to a downstream end of the lumen; an outerframe including a ring defined by a pattern of alternating peaks andtroughs, the peaks being longitudinally closer to the upstream end thanto the downstream end, and the troughs being longitudinally closer tothe downstream end than to the upstream end, and the pattern of the ringhaving an amplitude longitudinally between the peaks and the troughs,including a plurality of legs, each of the legs coupled to the ring at arespective trough, and shaped to define a plurality of outer-framecoupling elements, each of the outer-frame coupling elements coupled tothe ring at a respective peak, and fixed with respect to a respectivevalve-frame coupling element, and the tubular portion has a compressedstate in which the tubular portion has a compressed diameter, and anexpanded state in which the tubular portion has an expanded diameterthat is greater than the compressed diameter, and the fixation of theouter-frame coupling elements to the valve-frame coupling elements issuch that compression of the tubular portion from the expanded statetoward the compressed state such that the valve-frame coupling elementspull the outer-frame coupling elements radially inward reduces acircumferential distance between each of the outer-frame couplingelements and its adjacent outer-frame coupling elements, and increasesthe amplitude of the pattern of the ring.

In an embodiment, the ring circumscribes the tubular portion.

In an embodiment, the valve-frame coupling elements are disposedcircumferentially around the longitudinal axis between the upstream endand the downstream end but not at the upstream end nor at the downstreamend.

In an embodiment, the upstream support portion includes one or morefabric pockets disposed circumferentially, each pocket of the one ormore pockets having an opening that faces a downstream direction.

In an embodiment, the outer frame is coupled to the valve frame only viathe fixation of the outer-frame coupling elements to the respectivevalve-frame coupling elements.

In an embodiment, the apparatus further includes an upstream supportportion that includes a plurality of arms that extend radially from thetubular portion, and the upstream support portion has a constrained-armstate, and a released-arm state in which the arms extend radiallyoutward from the tubular portion, each leg has a tissue-engaging flangethat has a constrained-flange state, and a released-flange state inwhich the flange extends radially outward from the tubular portion, andthe apparatus has an intermediate state in which the tubular portion isin its compressed state, the upstream support portion is in itsreleased-arm state, and the legs are in their released-flange state.

In an embodiment, the apparatus includes an implant that includes thevalve frame, the leaflets, and the outer frame, and the apparatusfurther includes a tool including a delivery capsule dimensioned tohouse and retain the implant in a compressed state of the implant inwhich (a) the tubular portion is in its compressed state, (b) theupstream support portion is in its constrained-arm state, and (c) thelegs are in their constrained-flange state, and to be advancedpercutaneously to the heart of the subject while the implant is housedand in its compressed state, and operable from outside the subject totransition the implant from its compressed state into the intermediatestate while retaining the tubular portion in its compressed state, andsubsequently, expand the tubular portion toward its expanded state.

In an embodiment, the tool is operable from outside the subject totransition the implant from its compressed state into the intermediatestate by releasing the legs into their released-flange state, whileretaining the tubular portion in its compressed state, and subsequently,releasing the upstream support portion into its released-arm state,while retaining the tubular portion in its compressed state.

In an embodiment, the tool is operable from outside the subject totransition the implant from its compressed state into the intermediatestate by releasing the upstream support portion into its released-armstate, while retaining the tubular portion in its compressed state, andsubsequently, releasing the legs into their released-flange state, whileretaining the tubular portion in its compressed state.

In an embodiment, the fixation of the outer-frame coupling elements tothe valve-frame coupling elements is such that, when the apparatus is inits intermediate state, expansion of the tubular portion from itscompressed state toward its expanded state moves the flangeslongitudinally away from the valve-frame coupling elements.

In an embodiment, the fixation of the outer-frame coupling elements tothe valve-frame coupling elements is such that, when the apparatus is inits intermediate state, expansion of the tubular portion from acompressed state toward an expanded state reduces the amplitude of thepattern of the ring and passes the flanges between the arms.

In an embodiment, the upstream support portion further includes acovering that covers the arms to form an annular shape in thereleased-arm state, and, when the apparatus is in its intermediatestate, expansion of the tubular portion from its compressed state towardits expanded state presses the flanges onto the covering.

In an embodiment, in the compressed state of the tubular portion, adownstream end of each leg of the tubular portion is longitudinallycloser than the valve-frame coupling elements to the downstream end, andthe flange of each leg is disposed longitudinally closer than thevalve-frame coupling elements to the upstream end.

In an embodiment, in the expanded state of the tubular portion, thedownstream end of each leg is longitudinally closer than the valve-framecoupling elements to the downstream end, and the flange of each leg isdisposed longitudinally closer than the valve-frame coupling elements tothe upstream end.

In accordance with an embodiment of the present disclosure, an apparatusfor use with a native valve of a heart of a subject is provided, theapparatus having an implant that includes a valve frame that includes atubular portion that circumscribes a longitudinal axis of the valveframe so as to define a lumen along the axis, the tubular portion havingan upstream end, a downstream end, a longitudinal length therebetween,and a diameter transverse to the longitudinal axis; a valve member,coupled to the tubular portion, disposed within the lumen, and arrangedto provide unidirectional upstream-to-downstream flow of blood throughthe lumen; an upstream support portion, coupled to the tubular portion;and an outer frame, coupled to the tubular portion, and including atissue-engaging flange, and the implant has a first state and a secondstate, in both the first state and the second state, the upstreamsupport portion extends radially outward from the tubular portion, andthe tissue-engaging flange extends radially outward from the tubularportion, and the tubular portion, the upstream support portion, and theouter frame are arranged such that transitioning of the implant from thefirst state toward the second state increases the diameter of thetubular portion by a diameter-increase amount, decreases the length ofthe tubular portion by a length-decrease amount, and moves the flange alongitudinal distance toward or toward-and-beyond the upstream supportportion, the distance being greater than the length-decrease amount.

In an embodiment of the present disclosure, the tubular portion, theupstream support portion, and the outer frame may be arranged such thatthe longitudinal distance is more than 20 percent greater than thelength-decrease amount.

In an embodiment, the tubular portion, the upstream support portion, andthe outer frame may be arranged such that the longitudinal distance ismore than 30 percent greater than the length-decrease amount.

In an embodiment, the tubular portion, the upstream support portion, andthe outer frame may be arranged such that the longitudinal distance ismore than 40 percent greater than the length-decrease amount.

In accordance with an embodiment of the present disclosure, an apparatusfor use with a native valve that is disposed between an atrium and aventricle of a heart of a subject is provided, the apparatus including avalve frame, including a tubular portion that circumscribes alongitudinal axis of the valve frame so as to define a lumen along theaxis; a plurality of prosthetic leaflets, coupled to the frame, disposedwithin the lumen, and arranged to provide unidirectional flow of bloodfrom an upstream end of the lumen to a downstream end of the lumen; anouter frame, including a ring defined by a pattern of alternating peaksand troughs the peaks being longitudinally closer than the troughs tothe upstream end, the peaks being fixed to respective sites of thetubular portion at respective coupling points disposed circumferentiallyaround the longitudinal axis, and the pattern of the ring having anamplitude longitudinally between the peaks and the troughs; and aplurality of legs, each of the legs coupled to the ring at a respectivetrough, and the tubular portion has a compressed state in which thetubular portion has a compressed diameter, and an expanded state inwhich the tubular portion has an expanded diameter that is greater thanthe compressed diameter, and the fixation of the peaks to the respectivesites of the tubular portion is such that compression of the tubularportion from the expanded state toward the compressed state such thatthe respective sites of the tubular portion pull the peaks radiallyinward via radially-inward tension on the coupling points reduces acircumferential distance between each of the coupling points and itsadjacent coupling points, and increases the amplitude of the pattern ofthe ring.

In an embodiment, the outer frame may be coupled to the valve frame onlyvia the fixation of the peaks to the respective sites of the tubularportion at the respective coupling points.

In accordance with an embodiment of the present disclosure, an apparatusfor use with a native valve that is disposed between an atrium and aventricle of a heart of a subject is provided, the apparatus including avalve frame, including a tubular portion that circumscribes alongitudinal axis of the valve frame so as to define a lumen along theaxis, the valve frame defining a plurality of valve-frame couplingelements disposed circumferentially around the longitudinal axis; aplurality of prosthetic leaflets, coupled to the frame, disposed withinthe lumen, and arranged to provide unidirectional flow of blood from anupstream end of the lumen to a downstream end of the lumen; an outerframe including a ring defined by a pattern of alternating peaks andtroughs, the peaks being longitudinally closer to the upstream end thanto the downstream end, and the troughs being longitudinally closer tothe downstream end than to the upstream end, and the pattern of the ringhaving an amplitude longitudinally between the peaks and the troughs,including a plurality of legs, each of the legs coupled to the ring at arespective trough, and shaped to define a plurality of outer-framecoupling elements, each of the outer-frame coupling elements coupled tothe ring at a respective peak, and fixed with respect to a respectivevalve-frame coupling element, and the tubular portion has a compressedstate in which the tubular portion has a compressed diameter, and anexpanded state in which the tubular portion has an expanded diameterthat is greater than the compressed diameter, and the fixation of theouter-frame coupling elements with respect to the valve-frame couplingelements is such that compression of the tubular portion from theexpanded state toward the compressed state pulls the outer-framecoupling elements radially inward via radially-inward pulling of thevalve-frame coupling elements on the outer-frame coupling elements,reduces a circumferential distance between each of the outer-framecoupling elements and its adjacent outer-frame coupling elements, andincreases the amplitude of the pattern of the ring, without increasing aradial gap between the valve frame and the ring by more than 1.5 mm.

In an embodiment, the outer frame may be coupled to the valve frame onlyvia the fixation of the outer-frame coupling elements to the respectivevalve-frame coupling elements.

There is further provided, in accordance with an embodiment of thepresent disclosure, an apparatus for use with a native valve that isdisposed between an atrium and a ventricle of a heart of a subject isprovided, the apparatus including a valve frame, including a tubularportion that circumscribes a longitudinal axis of the valve frame so asto define a lumen along the axis; a plurality of prosthetic leaflets,coupled to the frame, disposed within the lumen, and arranged to provideunidirectional flow of blood from an upstream end of the lumen to adownstream end of the lumen; an outer frame, including a ring defined bya pattern of alternating peaks and troughs the peaks beinglongitudinally closer than the troughs to the upstream end, the peaksbeing fixed to respective sites of the tubular portion at respectivecoupling points disposed circumferentially around the longitudinal axis,and the pattern of the ring having an amplitude longitudinally betweenthe peaks and the troughs; and a plurality of legs, each of the legscoupled to the ring at a respective trough, and the tubular portion hasa compressed state in which the tubular portion has a compresseddiameter, and an expanded state in which the tubular portion has anexpanded diameter that is greater than the compressed diameter, and thefixation of the peaks to the respective sites of the tubular portion issuch that compression of the tubular portion from the expanded statetoward the compressed state pulls the peaks radially inward viaradially-inward pulling of the respective sites of the tubular portionon the peaks, reduces a circumferential distance between each of thecoupling points and its adjacent coupling points, and increases theamplitude of the pattern of the ring, without increasing a radial gapbetween the valve frame and the ring by more than 1.5 mm.

In an embodiment, the outer frame may be coupled to the valve frame onlyvia the fixation of the peaks to the respective sites of the tubularportion at the respective coupling points.

In accordance with an embodiment of the present disclosure, an apparatusfor use with a native valve disposed between an atrium and a ventricleof a heart of a subject is provided, the apparatus including a valveframe, including a tubular portion that circumscribes a longitudinalaxis of the valve frame so as to define a lumen along the axis, thetubular portion having an upstream end, a downstream end, and defining aplurality of valve-frame coupling elements disposed circumferentiallyaround the longitudinal axis between the upstream end and the downstreamend but not at the upstream end nor at the downstream end; a pluralityof prosthetic leaflets, disposed within the lumen, and arranged toprovide unidirectional flow of blood through the lumen; an outer frameincluding a ring defined by a pattern of alternating peaks and troughs,the peaks being longitudinally closer to the upstream end than to thedownstream end, and the troughs being longitudinally closer to thedownstream end than to the upstream end, including a plurality of legs,each of the legs coupled to the ring at a respective trough, and shapedto define a plurality of outer-frame coupling elements, each of theouter-frame coupling elements coupled to the ring at a respective peak,and fixed with respect to a respective valve-frame coupling element at arespective coupling point, and the tubular portion has a compressedstate in which the tubular portion has a compressed diameter, and anexpanded state in which the tubular portion has an expanded diameterthat is greater than the compressed diameter, and expansion of thetubular portion from the compressed state toward the expanded stateincreases a circumferential distance between each of the outer-framecoupling elements and its adjacent outer-frame coupling elements, andmoves the plurality of legs in a longitudinally upstream direction withrespect to the tubular portion.

In an embodiment, the outer frame may be coupled to the valve frame onlyvia the fixation of the outer-frame coupling elements to the respectivevalve-frame coupling elements.

In accordance with an embodiment of the present disclosure, an apparatusfor use with a native valve disposed between an atrium and a ventricleof a heart of a subject is provided, the apparatus including a valveframe, including a tubular portion that circumscribes a longitudinalaxis of the valve frame so as to define a lumen along the axis, thetubular portion having an upstream end and a downstream end; a pluralityof prosthetic leaflets, disposed within the lumen, and arranged toprovide unidirectional flow of blood through the lumen; an outer frame,including a ring defined by a pattern of alternating peaks and troughsthe peaks being longitudinally closer than the troughs to the upstreamend, the peaks being fixed to respective sites of the tubular portion atrespective coupling points disposed circumferentially around thelongitudinal axis between the upstream end and the downstream end butnot at the upstream end nor the downstream end; and a plurality of legs,each of the legs coupled to the ring at a respective trough, and thetubular portion has a compressed state in which the tubular portion hasa compressed diameter, and an expanded state in which the tubularportion has an expanded diameter that is greater than the compresseddiameter, and expansion of the tubular portion from the compressed statetoward the expanded state increases a circumferential distance betweeneach of the coupling points and its adjacent coupling points, and movesthe plurality of legs in a longitudinally upstream direction withrespect to the tubular portion.

In an embodiment, the outer frame may be coupled to the valve frame onlyvia the fixation of the peaks to the respective sites of the tubularportion at the respective coupling points.

In accordance with an embodiment of the present disclosure, an apparatusfor use with a native valve of a heart of a subject is provided, theapparatus including a frame assembly, having an upstream end and adownstream end, and a central longitudinal axis therebetween, andincluding a valve frame, including a tubular portion having an upstreamend and a downstream end, and shaped to define a lumen therebetween, andan upstream support portion, extending from the upstream end of thetubular portion; and at least one leg, coupled to the valve frame at acoupling point, and having a tissue-engaging flange; and a valve memberdisposed within the lumen, and configured to facilitate one-way liquidflow through the lumen from the upstream end of the tubular portion tothe downstream end of the tubular portion, and the frame assembly has acompressed state, for percutaneous delivery to the heart, in which thetubular portion has a compressed diameter, is biased to assume anexpanded state in which the tubular portion has an expanded diameterthat is greater than the compressed diameter, and is configured suchthat increasing the diameter of the tubular portion toward the expandeddiameter causes longitudinal movement of the upstream support portiontoward the coupling point, and of the tissue-engaging flange away fromthe coupling point.

In an embodiment the apparatus includes an implant that includes theframe assembly and the valve member, and the apparatus further includesa tool including a delivery capsule dimensioned to house and retain theimplant in the compressed state, and to be advanced percutaneously tothe heart of the subject while the implant is housed and in thecompressed state, and operable from outside the subject to facilitate anincrease of the diameter of the tubular portion from the compresseddiameter toward the expanded diameter such that the increase of thediameter actuates longitudinal movement of the upstream support portiontoward the coupling point, and of the tissue-engaging flange away fromthe coupling point.

In an embodiment, the frame assembly may be configured such thatincreasing the diameter of the tubular portion by expanding the frameassembly toward the expanded state causes longitudinal movement of theupstream end of the tubular portion toward the coupling point.

In an embodiment, the coupling point is disposed closer to thedownstream end of the frame assembly than are either the tissue-engagingflange or the upstream support portion.

In an embodiment, in the expanded state of the frame assembly, the legextends away from the central longitudinal axis.

In an embodiment, the expanded state of the frame assembly may be afully-expanded state of the frame assembly, the leg is expandable intoan expanded state of the leg, independently of increasing the diameterof the tubular portion, and in the expanded state of the leg, the legextends away from the central longitudinal axis.

In an embodiment, in the expanded state of the frame assembly, the legextends away from the central longitudinal axis, and in the compressedstate of the frame assembly, the leg is generally parallel with thecentral longitudinal axis.

In an embodiment, the frame assembly may be configured such that thelongitudinal movement of the tissue-engaging flange away from thecoupling point is a translational movement of the tissue-engaging flangethat does not include rotation of the tissue-engaging flange.

In an embodiment, the frame assembly may be configured such thatincreasing the diameter of the tubular portion by expanding the frameassembly toward the expanded state causes 1-20 mm of longitudinalmovement of the tissue-engaging flange away from the coupling point.

In an embodiment, the frame assembly may be configured such thatincreasing the diameter of the tubular portion by expanding the frameassembly toward the expanded state causes 1-20 mm of longitudinalmovement of the upstream support portion toward the coupling point.

In an embodiment, the frame assembly may be configured such thatincreasing the diameter of the tubular portion by expanding the frameassembly toward the expanded state reduces a distance between theupstream support portion and the tissue-engaging flange by 5-30 mm.

In an embodiment, the frame assembly may be configured such thatincreasing the diameter of the tubular portion by expanding the frameassembly toward the expanded state moves the tissue-engaging flangelongitudinally past the upstream support portion.

In an embodiment, the tubular portion may be defined by a plurality ofcells of the valve frame, and increasing the diameter of the tubularportion by expanding the frame assembly toward the expanded stateincludes increasing a width, orthogonal to the longitudinal axis of theframe assembly, of each cell, and reducing a height, parallel with thelongitudinal axis of the frame assembly, of each cell, and causeslongitudinal movement of the upstream support portion toward thecoupling point by reducing a height, parallel with the longitudinal axisof the frame assembly, of the tubular portion, by reducing the height ofeach cell.

In an embodiment, the leg is disposed on an outside of the tubularportion.

In an embodiment, the at least one leg includes a plurality of legs, thecoupling point includes a plurality of coupling points, and the frameassembly includes a leg frame that circumscribes the tubular portion,includes the plurality of legs, and is coupled to the valve frame at theplurality of coupling points, such that the plurality of legs isdistributed circumferentially around the tubular portion.

In an embodiment, the plurality of coupling points is disposedcircumferentially around the frame assembly on a transverse plane thatis orthogonal to the longitudinal axis of the frame assembly.

In an embodiment, the plurality of legs may be coupled to the valveframe via a plurality of struts, each strut having a first end that iscoupled to a leg of the plurality of legs, and a second end that iscoupled to a coupling point of the plurality of coupling points, in thecompressed state of the frame assembly, being disposed at a first anglein which the first end is disposed closer to the downstream end of theframe assembly than is the second end, and being deflectable withrespect to the coupling point of the plurality of coupling points, suchthat increasing the diameter of the tubular portion by expanding theframe assembly toward the expanded state causes the strut to deflect toa second angle in which the first end is disposed further from thedownstream end of the frame assembly than is the first end in thecompressed state of the frame assembly.

In an embodiment, the leg frame may be structured such that each leg ofthe plurality of legs is coupled to two struts of the plurality ofstruts, and two struts of the plurality of struts are coupled to eachcoupling point of the plurality of coupling points.

In an embodiment, the leg may be coupled to the valve frame via a strut,the strut having a first end that is coupled to the leg, and a secondend that is coupled to the coupling point, in the compressed state ofthe frame assembly, being disposed at a first angle in which the firstend is disposed closer to the downstream end of the frame assembly thanis the second end, and being deflectable with respect to the couplingpoint, such that increasing the diameter of the tubular portion byexpanding the frame assembly toward the expanded state causes the strutto deflect to a second angle in which the first end is disposed furtherfrom the downstream end of the frame assembly than is the first end inthe compressed state of the frame assembly.

In an embodiment, the at least one leg includes at least a first leg anda second leg.

In an embodiment, the first leg and the second leg are both coupled tothe valve frame at the coupling point.

In an embodiment, the first leg may be coupled to the coupling point viaa respective first strut, and the second leg is coupled to the couplingpoint via a respective second strut.

In an embodiment, the first and second legs, the first and secondstruts, and the coupling point are arranged such that, in the expandedstate of the frame assembly the coupling point is disposed,circumferentially with respect to the tubular portion, between the firststrut and the second strut, the first strut is disposed,circumferentially with respect to the tubular portion, between thecoupling point and the first leg, and the second strut is disposed,circumferentially with respect to the tubular portion, between thecoupling point and the second leg.

In an embodiment, the coupling point includes at least a first couplingpoint and a second coupling point.

In an embodiment, the leg is coupled to the valve frame at the firstcoupling point and at the second coupling point.

In an embodiment, the leg may be coupled to the first coupling point viaa respective first strut, and to the second coupling point via arespective second strut.

In an embodiment, the first and second legs, the first and secondstruts, and the coupling point are arranged such that, in the expandedstate of the frame assembly the leg is disposed, circumferentially withrespect to the tubular portion, between the first strut and the secondstrut, the first strut is disposed, circumferentially with respect tothe tubular portion, between the leg and the first coupling point, andthe second strut is disposed, circumferentially with respect to thetubular portion, between the leg and the second coupling point.

In an embodiment, in the expanded state of the frame assembly, theupstream support portion extends radially outward from the tubularportion.

In an embodiment, the expanded state of the frame assembly is afully-expanded state of the frame assembly, the upstream support portionis expandable into an expanded state of the upstream support portion,independently of increasing the diameter of the tubular portion, and inthe expanded state of the upstream support portion, the upstream supportportion extends radially outward from the tubular portion.

In an embodiment, in the compressed state of the frame assembly, theupstream support portion is generally tubular, collinear with thetubular portion, and disposed around the central longitudinal axis.

In an embodiment, in the expanded state of the frame assembly, an innerregion of the upstream support portion extends radially outward from thetubular portion at a first angle with respect to the tubular portion,and an outer region of the upstream support portion extends, from theinner region of the upstream support portion, further radially outwardfrom the tubular portion at a second angle with respect to the tubularportion, the second angle being smaller than the first angle.

In accordance with an embodiment of the present disclosure, an apparatusfor use with a native valve of a heart of a subject is provided, theapparatus including a frame assembly, having an upstream end and adownstream end, and a central longitudinal axis therebetween, andincluding a valve frame, including a tubular portion having an upstreamend and a downstream end, and shaped to define a lumen therebetween, andan upstream support portion, extending from the upstream end of thetubular portion; and at least one leg, coupled to the valve frame at acoupling point, and having a tissue-engaging flange; and a valve memberdisposed within the lumen, and configured to facilitate one-way liquidflow through the lumen from the upstream end of the tubular portion tothe downstream end of the tubular portion, and the frame assembly has acompressed state, for percutaneous delivery to the heart, in which thetubular portion has a compressed diameter, is biased to assume anexpanded state in which the tubular portion has an expanded diameterthat is greater than the compressed diameter, and is configured suchthat reducing the diameter of the tubular portion toward the compresseddiameter causes longitudinal movement of the upstream support portionaway from the coupling point, and of the tissue-engaging flange towardthe coupling point.

In accordance with an embodiment of the present disclosure, an apparatusfor use with a native valve of a heart of a subject is provided, theapparatus including a frame assembly, having an upstream end and adownstream end, and a central longitudinal axis therebetween, includinga valve frame, including a tubular portion having an upstream end and adownstream end, and shaped to define a lumen therebetween, and anupstream support portion, extending from the upstream end of the tubularportion; and at least one leg, coupled to the valve frame at a couplingpoint, and having a tissue-engaging flange; and a valve member disposedwithin the lumen, and configured to facilitate one-way liquid flowthrough the lumen from the upstream end of the tubular portion to thedownstream end of the tubular portion, and the frame assembly has acompressed state, for percutaneous delivery to the heart, isintracorporeally expandable into an expanded state in which a diameterof the tubular portion is greater than in the compressed state, and isconfigured such that increasing the diameter of the tubular portion byexpanding the frame assembly toward the expanded state causeslongitudinal movement of the tissue-engaging flange away from thecoupling point.

In accordance with an embodiment of the present disclosure, an apparatusfor use with a native valve of a heart of a subject is provided, theapparatus including a frame assembly, having an upstream end and adownstream end, and a central longitudinal axis therebetween, andincluding an inner frame including an inner-frame tubular portion thatcircumscribes the central longitudinal axis, has an upstream end and adownstream end, and defines a channel therebetween, the inner framedefining a plurality of inner-frame couplings disposed circumferentiallyat a longitudinal location of the inner frame, an outer frame includingan outer-frame tubular portion that coaxially circumscribes at least aportion of the inner-frame tubular portion, the outer frame defining aplurality of outer-frame couplings disposed circumferentially at alongitudinal location of the outer frame, and a plurality of connectors,each connector connecting a respective inner-frame coupling to arespective outer-frame coupling; a liner, disposed over at least part ofthe inner-frame tubular portion; and a plurality of prosthetic leaflets,coupled to the inner-frame tubular portion and disposed within thechannel, and the frame assembly is compressible by aradially-compressive force into a compressed state in which the innerframe is in a compressed state thereof and the outer frame is in acompressed state thereof, is configured, upon removal of theradially-compressive force, to automatically expand into an expandedstate thereof in which the inner frame is in an expanded state thereofand the outer frame is in an expanded state thereof, in the expandedstate of the frame assembly, the prosthetic leaflets are configured tofacilitate one-way fluid flow, in a downstream direction, through thechannel, and the connection of the inner-frame couplings to therespective outer-frame couplings is such that expansion of the frameassembly from the compressed state to the expanded state causes theinner-frame tubular portion to slide longitudinally in a downstreamdirection with respect to the outer-frame tubular portion.

In accordance with an embodiment of the present disclosure, an apparatusfor use with a native valve disposed between an atrium and a ventricleof a heart of a subject is provided, the apparatus including a tubularportion, having an upstream portion that includes an upstream end, and adownstream portion that includes a downstream end, and shaped to definea lumen between the upstream portion and the downstream portion; aplurality of prosthetic leaflets, disposed within the lumen, andarranged to provide unidirectional flow of blood from the upstreamportion to the downstream portion; an annular upstream support portionhaving an inner portion that extends radially outward from the upstreamportion, and including one or more fabric pockets disposedcircumferentially around the inner portion, each pocket of the one ormore pockets having an opening that faces a downstream direction.

In an embodiment, the upstream support portion includes a plurality ofarms that extend radially outward from the tubular portion, and acovering, disposed over the plurality of arms, each arm has aradially-inner part at the inner portion of the upstream supportportion, and a radially-outer part at the outer portion of the upstreamsupport portion, at the inner portion of the upstream support portion,the covering is closely-fitted between the radially-inner parts of thearms, and at the outer portion of the upstream support portion, thepockets are formed by the covering being loosely-fitted between theradially-outer parts of the arms.

In an embodiment, the upstream support portion includes a plurality ofarms that extend radially outward from the tubular portion, and acovering, disposed over the plurality of arms, each arm has aradially-inner part at the inner portion of the upstream supportportion, and a radially-outer part at the outer portion of the upstreamsupport portion, the radially-outer part being more flexible than theradially-inner part.

In an embodiment, the upstream support portion includes a plurality ofarms that extend radially outward from the tubular portion, and acovering, disposed over the plurality of arms, each arm has aradially-inner part at the inner portion of the upstream supportportion, and a radially-outer part at the outer portion of the upstreamsupport portion, at the outer portion of the upstream support portion,the pockets are formed by each arm curving to form a hook shape.

In an embodiment, each pocket may be shaped and arranged to billow inresponse to perivalvular flow of blood in an upstream direction.

In an embodiment, the apparatus may be configured to be transluminallydelivered to the heart and implanted at the native valve by expansion ofthe apparatus, such that the upstream support portion is disposed in theatrium and the tubular portion extends from the upstream support portioninto the ventricle, and each pocket is shaped and arranged such thatperivalvular flow of blood in an upstream direction presses the pocketagainst tissue of the atrium.

In accordance with an embodiment of the present disclosure, an apparatusis provided including a plurality of prosthetic valve leaflets; and aframe assembly, including a tubular portion defined by a repeatingpattern of cells, the tubular portion extending circumferentially arounda longitudinal axis so as to define a longitudinal lumen, the prostheticvalve leaflets coupled to the inner frame and disposed within the lumen;an outer frame, including a plurality of legs, distributedcircumferentially around the tubular portion, each leg having atissue-engaging flange; an upstream support portion that includes aplurality of arms that extend radially outward from the tubular portion;and a plurality of appendages, each having a first end that defines acoupling element via which the tubular portion is coupled to the outerframe, and a second end; and the frame assembly defines a plurality ofhubs, distributed circumferentially around the longitudinal axis on aplane that is transverse to the longitudinal axis, each hub defined byconvergence and connection of, two adjacent cells of the tubularportion, an arm of the plurality of arms, and an appendage of theplurality of appendages.

In an embodiment, each hub has six radiating spokes, two of the sixspokes being part of a first cell of the two adjacent cells, two of thesix spokes being part of a second cell of the two adjacent cells, one ofthe six spokes being the arm, and one of the six spokes being the secondend of the appendage.

In an embodiment, the appendages are in-plane with the tubular portion.

In an embodiment, the appendages are in-plane with the outer frame.

In accordance with an embodiment of the present disclosure, a method foruse with a native valve of a heart of a subject is provided, the methodincluding percutaneously advancing to heart, an implant including avalve frame, a valve member disposed within a lumen defined by the valveframe, and at least one leg, coupled to the valve frame at a couplingpoint, and having an upstream end, a downstream end, and a centrallongitudinal axis therebetween; positioning the implant within the heartsuch that a tissue-engaging flange of the leg is disposed downstream ofthe valve, and thereafter causing the flange to protrude radiallyoutward from the axis; subsequently, while an upstream support portionof the valve frame is disposed upstream of the valve, causing theupstream support portion to protrude radially outward from the axis,such that tissue of the valve is disposed between the upstream supportportion and the flange; and subsequently, sandwiching the tissue betweenthe upstream support portion and the flange by reducing a distancebetween the upstream support portion and the flange by causinglongitudinal movement of the upstream support portion toward thecoupling point, and of the tissue-engaging flange away from the couplingpoint.

In an embodiment, causing the longitudinal movement of the upstreamsupport portion toward the coupling point, and of the tissue-engagingflange away from the coupling point, includes causing the longitudinalmovement by increasing a diameter of the lumen.

In accordance with an embodiment of the present disclosure, a method foruse with a native valve of a heart of a subject is provided, the methodincluding percutaneously advancing to heart, an implant including avalve frame, a valve member disposed within a lumen defined by the valveframe, and at least one leg, coupled to the valve frame at a couplingpoint, and having an upstream end, a downstream end, and a centrallongitudinal axis therebetween; positioning the implant within the heartsuch that an upstream support portion of the valve frame is disposedupstream of the valve, and thereafter causing the upstream supportportion to protrude radially outward from the axis; subsequently, whilea tissue-engaging flange of the leg is disposed downstream of the valve,causing the tissue-engaging flange to protrude radially outward from theaxis, such that tissue of the valve is disposed between the upstreamsupport portion and the flange; and subsequently, sandwiching the tissuebetween the upstream support portion and the flange by reducing adistance between the upstream support portion and the flange by causinglongitudinal movement of the upstream support portion toward thecoupling point, and of the tissue-engaging flange away from the couplingpoint.

In an embodiment, causing the longitudinal movement of the upstreamsupport portion toward the coupling point, and of the tissue-engagingflange away from the coupling point, includes causing the longitudinalmovement by increasing a diameter of the lumen.

In accordance with an embodiment of the present disclosure, a method foruse with a native valve of a heart of a subject is provided, the methodincluding percutaneously advancing an implant to the heart, the implanthaving an upstream end, a downstream end, and a central longitudinalaxis therebetween, and including a tubular portion, an upstream supportportion, and a plurality of tissue-engaging flanges; positioning theimplant within the heart such that the upstream support portion isdisposed upstream of the valve, positioning the implant within the heartsuch that the tissue-engaging flanges are disposed downstream of thevalve, without increasing a diameter of the tubular portion causing theupstream support portion to extend radially outward from the axis so asto have a first support-portion span, and causing the flanges to extendradially outward from the axis so as to have a first flange span; andsubsequently, causing the upstream support portion and the flanges movetoward each other by at least 5 mm by increasing a diameter of thetubular portion such that the upstream support portion extends radiallyoutward so as to have a second support-portion span, the firstsupport-portion span being at least 40 percent as great as the secondsupport-portion span, and the flanges extend radially outward so as tohave a second flange span, the first flange span being at least 30percent as great as the second flange span.

There is further provided, in accordance with an embodiment of thepresent disclosure, a method for use with a native valve of a heart of asubject, the method including percutaneously advancing an implant to theheart, the implant having an upstream end, a downstream end, and acentral longitudinal axis therebetween, and including a tubular portion,an upstream support portion, and a plurality of tissue-engaging flanges;positioning the implant within the heart such that the upstream supportportion is disposed upstream of the valve, positioning the implantwithin the heart such that the tissue-engaging flanges are disposeddownstream of the valve, without increasing a diameter of the tubularportion causing the upstream support portion to extend radially outwardfrom the axis, and causing the flanges to extend radially outward fromthe axis so as to have a first flange span; and subsequently, byincreasing a diameter of the tubular portion causing the upstreamsupport portion and the flanges move toward each other by at least 5 mm,causing the upstream support portion to move further radially outwardfrom the axis, and causing each flange of the plurality of flanges totranslate radially outward so as to have a second flange span that isgreater than the first flange span.

The present disclosure will be more fully understood from the followingdetailed description of embodiments thereof, taken together with thedrawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-B and 2A-E are schematic illustrations of an implant for usewith a native valve of a heart of a subject, in accordance with someembodiments of the disclosure;

FIGS. 3A-C are schematic illustrations that show structural changes in aframe assembly during transitioning of the assembly between itscompressed and expanded states, in accordance with some embodiments ofthe disclosure;

FIGS. 4A-F are schematic illustrations of implantation of the implant atthe native valve, in accordance with some embodiments of the disclosure;

FIG. 5 is a schematic illustration of a step in the implantation of theimplant, in accordance with some embodiments of the disclosure;

FIG. 6 is a schematic illustration of the implant, in accordance withsome embodiments of the disclosure;

FIGS. 7A-B and 8A-B are schematic illustrations of frame assemblies ofrespective implants, in accordance with some embodiments of thedisclosure; and

FIGS. 9A-C are schematic illustrations of an implant including a frameassembly, in accordance with some embodiments of the disclosure.

DETAILED DESCRIPTION OF EMBODIMENTS

Reference is made to FIGS. 1A-B and 2A-E, which are schematicillustrations of an implant 20 (alternatively, “prosthetic valve 20”)for use with a native valve of a heart of a subject, in accordance withsome embodiments of the disclosure. Prosthetic valve 20 includes a frameassembly 22 that has an upstream end 24 (alternatively, “atrial end24”), a downstream end 26 (alternatively, “ventricular end 26”), and acentral longitudinal axis ax1 therebetween. The term “atrial end” mayrefer to an end of a given feature which is configured to be situatedclosest to an atrium of the heart when prosthetic valve 20 is implantedtherein. For example, in FIGS. 1A, 1B, and 2A-2E, the atrial end ofprosthetic valve 20 may be the top end of prosthetic valve 20.Similarly, the term “ventricular end” may refer to an end of a givenfeature which is configured to be situated closest to a ventricle of theheart when prosthetic valve 20 is implanted therein. For example, inFIGS. 1A, 1B, and 2A-2E, the ventricular end of prosthetic valve 20 maybe the bottom end of prosthetic valve 20. Frame assembly 22 includes avalve frame 30 (alternatively, “inner frame 30”) that includes a tubularportion 32 (alternatively, “inner frame tubular portion 32”) which isconstructed of struts 85 and which has an atrial end 34 and aventricular end 36, and is shaped to define a lumen 38 through the innerframe tubular portion 32 from the atrial end 34 to the ventricular end36. Inner frame tubular portion 32 circumscribes axis ax1, and therebydefines lumen 38 along the axis. Inner frame 30 further includes anupstream support portion 40, extending from atrial end 34 of inner frametubular portion 32. Frame assembly 22 further includes at least one leg50 (alternatively, “ventricular anchor support 50”), coupled to innerframe 30 at (e.g., via) a coupling point 52, and having atissue-engaging flange 54 (alternatively, “ventricular anchoring leg54”). As illustrated in FIG. 1B, ventricular anchoring legs 54 mayextend from outer frame 60. In particular, and as illustrated in FIGS.1B and 3A, each ventricular anchoring leg 54 may extend from junction 53of outer frame 60. Junction 53 may be the intersection betweenventricular anchoring leg 54, ventricular anchoring support 50, andconnectors 78. Thus, junction 53 may form a point of connection betweenventricular anchoring leg 54 and outer frame 60.

In some embodiments, and as described hereinbelow, ventricular anchorsupport 50 is part of an outer frame 60, and frames 30 and 60 definerespective coupling elements 31 and 61, which are fixed with respect toeach other at coupling points 52. As illustrated in FIG. 1A, inner frame30 may be positioned at least partially within outer frame 60. In someembodiments, frames 30 and 60 are coupled to each other only at couplingpoints 52 (e.g., only via the fixation of coupling elements 31 and 61with respect to each other).

Prosthetic valve 20 further includes a valve member 58 (e.g., one ormore prosthetic leaflets) disposed within lumen 38, and configured tofacilitate one-way liquid flow through the lumen from atrial end 34 toventricular end 36 (e.g., thereby defining the orientation of the atrialand ventricular ends of inner frame tubular portion 32). FIG. 1A showsprosthetic valve 20 in a fully-expanded state, in which frame assembly22 is in a fully-expanded state. FIG. 1B shows an exploded view of frameassembly 22 in its fully-expanded state. FIGS. 2A-E show respectivestates of prosthetic valve 20, which will be discussed in more detailhereinbelow with respect to the implantation of the prosthetic valve andthe anatomy in which the prosthetic valve is implanted. FIG. 2A showsprosthetic valve 20 in a compressed state in which frame assembly 22 isin a compressed state for percutaneous delivery of the prosthetic valveto the heart of the subject. As illustrated in FIGS. 4A and 4B, frameassembly 22 may be in the compressed state when it is constrained withindelivery device 89 during delivery to the heart; thus, the compressedstate of frame assembly 22 illustrated in FIG. 2A may also constitute acontracted delivery configuration of the frame assembly 22. In someembodiments, in the contracted delivery configuration, ventricularanchor support 50 (including ventricular anchoring leg 54 thereof) is ina radially constrained state in which the ventricular anchoring leg isgenerally parallel with axis ax1. For example, ventricular anchorsupport 50 (including ventricular anchoring leg 54) may be in thedelivery configuration and extending in an upstream, atrial directiontowards atrium 6 when radially constrained within delivery device 89, asillustrated in FIG. 4A. Further in some embodiments, in the contracteddelivery configuration, upstream support portion 40 is generallytubular, collinear with inner frame tubular portion 32 (e.g., extendingcollinearly from the inner frame tubular portion), and disposed aroundaxis ax1. For example, upstream support portion 40 may be in thedelivery configuration when radially constrained within delivery device89, as illustrated in FIG. 4A.

The term “atrial direction” may refer to a direction extending upstreamfrom prosthetic valve 20, towards an atrium of the heart. For example,in FIGS. 4A-4E, an “atrial direction” may refer to a direction extendingupstream from the valve towards left atrium 6. The term “ventriculardirection” may refer to a direction extending downstream from prostheticvalve 20, towards a ventricle of the heart. In some embodiments, an“atrial direction” may be angled radially inward or outward fromprosthetic valve 20, so long as it also is angled upstream (towards anatrium) and not downstream (towards a ventricle); that is, an “atrialdirection” need not necessarily be parallel to longitudinal axis ax1,although it may be parallel to longitudinal axis ax1 in someembodiments. Similarly, a “ventricular direction” may be angled radiallyinward or outward from prosthetic valve 20, so long as it also is angleddownstream, towards a ventricle. For example, in FIGS. 4A-4F, a“ventricular direction” may refer to a direction extending downstream(downwards in FIGS. 4A-4F) from the valve towards the left ventricle. A“ventricular direction” need not necessarily be parallel to longitudinalaxis ax1, although it may be parallel to longitudinal axis ax1 in someembodiments.

FIG. 2B shows a state of prosthetic valve 20 in which ventricularanchoring leg 54 of each ventricular anchor support 50, includingterminal ends 55 thereof, extends radially away from axis ax1 (e.g.,radially away from inner frame tubular portion 32) in an unconstrainedconfiguration. FIG. 2C shows a state of prosthetic valve 20 in whichupstream support portion 40 (including the terminal ends 47 of atrialanchoring arms 46) extends radially away from axis ax1 (and therebyradially away from inner frame tubular portion 32) in an unconstrainedconfiguration. FIG. 2D shows a state of prosthetic valve 20 in whichboth ventricular anchoring leg 54 and upstream support portion 40 extendaway from axis ax1 in their respective unconstrained configurations. Inthe fully-expanded state (FIGS. 1A-B) (that is, an unconstrainedconfiguration of annular valve body 25) both upstream support portion 40and ventricular anchoring leg 54 extend radially away from axis ax1. Insome embodiments, frame assembly 22 is biased (e.g., shape-set) toassume its unconstrained configuration, which is shown in FIG. 2E.Transitioning of prosthetic valve 20 between the respectiveconfigurations may be controlled by a delivery apparatus, such as byconstraining the prosthetic valve in a contracted delivery configurationwithin a delivery tube and/or against a control rod, and selectivelyreleasing portions of the prosthetic valve to allow them to expand. Asalso illustrated in FIGS. 2D and 2E, expansion of annular valve body 25from the contracted delivery configuration (FIG. 2D) to thefully-expanded, unconstrained configuration (FIG. 2E) may shift pointsof connection 45 and 53 radially outward.

In the contracted delivery configuration of frame assembly 22, innerframe tubular portion 32 has a diameter d1, and in the unconstrainedconfiguration, the inner frame tubular portion has a diameter d2 that isgreater that diameter d1. For some embodiments, diameter d1 is 4-15 mm,(e.g., 5-11 mm) and diameter d2 is 20-50 mm, (e.g., 23-33 mm). Frameassembly 22 is configured such that increasing the diameter of innerframe tubular portion 32 (e.g., from d1 to d2) causes longitudinalmovement of ventricular anchoring leg 54 away from coupling point 52. Inthe same way, reducing the diameter of inner frame tubular portion 32(e.g., from d2 to d1) causes longitudinal movement of ventricularanchoring leg 54 toward coupling point 52. It is to be noted that theterm “longitudinal movement” (including the specification and theclaims) means movement parallel with central longitudinal axis ax1.Therefore longitudinal movement of ventricular anchoring leg 54 awayfrom coupling point 52 means increasing a distance, measured parallelwith longitudinal axis ax1, between ventricular anchoring leg 54 andcoupling point 52. An example of such a configuration is described inmore detail with respect to FIG. 3A.

Thus, expansion of inner frame tubular portion 32 from its contracteddelivery configuration toward its unconstrained configuration increasesa circumferential distance between each of coupling points 52 and itsadjacent coupling points (e.g., between each of outer-frame couplingelements 61 and its adjacent outer-frame coupling elements) (e.g., fromd8 to d9), and moves ventricular anchor supports 50 in a longitudinallyupstream direction with respect to the inner frame tubular portion (thatis, in an atrial direction).

In some embodiments, frame assembly 22 is configured such thatincreasing the diameter of inner frame tubular portion 32 also causeslongitudinal movement of upstream support portion 40 toward couplingpoint 52, e.g., as described in more detail with respect to FIGS. 3B-C.In some embodiments, frame assembly 22 is configured such thatincreasing the diameter of inner frame tubular portion 32 also causeslongitudinal movement of atrial end 34 of inner frame tubular portion 32toward coupling point 52. In the same way, reducing the diameter ofinner frame tubular portion 32 causes longitudinal movement of atrialend 34 away from coupling point 52.

For some embodiments, upstream support portion 40 includes a pluralityof atrial anchoring arms 46 that each extends radially outward frominner frame tubular portion 32 (e.g., from atrial end 34 of the innerframe tubular portion 32). In particular, and as illustrated in FIGS. 1Band 30, each atrial anchoring arm 46 may extend from junction 45 ofinner frame 30. Junction 45 may be the intersection between atrialanchoring arm 46 and struts 85. Thus, junction 45 may form a point ofconnection between atrial anchoring arm 46 and inner frame 30. In someembodiments, and as illustrated in FIG. 2C, the terminal ends 47 of thearms may deflect radially outward from annular valve body 25 when theatrial anchoring arms 46 assume the unconstrained configuration. Atrialanchoring arms 46 may be flexible. For some such embodiments, atrialanchoring arms 46 are coupled to inner frame tubular portion 32 suchthat each atrial anchoring arm 46 may deflect independently of adjacentatrial anchoring arms during implantation (e.g., due to anatomicaltopography).

For some embodiments, upstream support portion 40 includes a pluralityof barbs 48 that extend out of a ventricular surface of the upstreamsupport portion 40. For example, each atrial anchoring arm 46 mayinclude one or more of barbs 48. Barbs 48 press into tissue upstream ofthe native valve (e.g., into the valve annulus), thereby inhibitingdownstream movement of prosthetic valve 20 (in addition to inhibition ofdownstream movement provided by the geometry of upstream support portion40).

One or more surfaces of frame assembly 22 are covered with a covering23, which may include a flexible sheet, such as a fabric, e.g.,including polyester. In some embodiments, covering 23 covers at leastpart of inner frame tubular portion 32, in some embodiments lining aninner surface of the inner frame tubular portion, and thereby defininglumen 38.

Further in some embodiments, upstream support portion 40 is covered withcovering 23, e.g., extending between atrial anchoring arms 46 to form anannular shape. It is hypothesized that this reduces a likelihood ofparavalvular leakage. For such embodiments, excess covering 23 may beprovided between atrial anchoring arms 46 of upstream support portion40, so as to facilitate their independent movement. Although FIG. 1Ashows covering 23 covering an atrial side of upstream support portion40, the covering may additionally or alternatively cover the ventricularside of the upstream support portion. For example, covering 23 mayextend over the terminal ends 47 of atrial anchoring arms 46 and downthe outside of the atrial anchoring arms 46, or a separate piece ofcovering may be provided on the ventricular side of the upstream supportportion 40.

Alternatively, each atrial anchoring arm 46 may be individually coveredin a sleeve of covering 23, thereby facilitating independent movement ofthe atrial anchoring arms 46.

For some embodiments, at least part of ventricular anchor supports 50(e.g., ventricular anchoring legs 54 thereof) is covered with covering23.

In some embodiments, frame assembly 22 includes a plurality ofventricular anchor supports 50 (e.g., two or more supports, e.g., 2-16supports, such as 4-12 supports, such as 6-12 supports), arrangedcircumferentially around inner frame 30 (e.g., around the outside ofinner frame tubular portion 32). In some embodiments, frame assembly 22includes a plurality of coupling points 52 at which the ventricularanchor supports 50 are coupled to inner frame 30.

As described in more detail hereinbelow (e.g., with reference to FIG.3A), each ventricular anchor support 50 may be coupled to a couplingpoint 52 via a strut 70. For some embodiments, each ventricular anchorsupport 50 is coupled to a plurality of (e.g., two) coupling points 52via a respective plurality of (e.g., two) struts 70. For some suchembodiments, frame assembly 22 is arranged such that, in theunconstrained configuration of the frame assembly, ventricular anchorsupport 50 is disposed, circumferentially with respect to inner frametubular portion 32, between two struts, and each of the two struts aredisposed, circumferentially with respect to the inner frame tubularportion 32, between the ventricular anchor support 50 and a respectivecoupling point 52.

For some embodiments, a plurality of (e.g., two) ventricular anchorsupports 50 are coupled to each coupling point 52 via a respectiveplurality of (e.g., two) struts 70. For some such embodiments, frameassembly 22 is arranged such that, in the unconstrained configuration ofthe frame assembly, coupling point 52 is disposed, circumferentiallywith respect to inner frame tubular portion 32, between two struts 70,and each of the two struts are disposed, circumferentially with respectto the inner frame tubular portion 32, between the coupling point 52 anda respective ventricular anchor support 50.

For some embodiments, frame assembly 22 includes an outer frame 60 thatcircumscribes inner frame tubular portion 32, includes (or defines) theplurality of ventricular anchor supports 50 and the plurality of struts70, and is coupled to inner frame 30 at the plurality of coupling points52, such that the plurality of ventricular anchor supports 50 aredistributed circumferentially around the inner frame tubular portion.For such embodiments, outer frame 60 includes a ring 66 that is definedby a pattern of alternating peaks 64 and troughs 62, and that in someembodiments circumscribes inner frame tubular portion 32. For example,the ring may include struts 70, extending between the peaks 64 andtroughs 62. Peaks 64 are longitudinally closer to atrial end 34 of innerframe tubular portion 32 than to ventricular end 36, and troughs 62 arelongitudinally closer to the ventricular end than to the atrial end. (Itis to be noted that throughout this disclosure, the term“longitudinally” means with respect to longitudinal axis ax1. Forexample, “longitudinally closer” means closer along axis ax1 (whetherpositioned on axis ax1 or lateral to axis ax1), and “longitudinalmovement” means a change in position along axis ax1 (which may be inadditional to movement toward or away from axis ax1).) Therefore, peaks64 are closer than troughs 62 to atrial end 34, and troughs 62 arecloser than peaks 64 to ventricular end 36. As illustrated in FIG. 1B,outer frame 60 may include multiple rings 66; in embodiments depicted inFIG. 1B, outer frame 60 includes two rings 66 connected by ventricularanchor supports 50. Rings 66 and ventricular anchor supports 50 may forman annular outer frame tubular portion 65. Outer frame tubular portion65 may have an atrial end 67 and a ventricular end 69, and maycircumscribe axis ax1. In some embodiments, atrial end 67 may constitutea portion of the most upstream ring 66 and ventricular end 69 mayconstitute a portion of the most downstream ring 66. As also illustratedin FIG. 1B, ventricular anchoring legs 54 may extend from outer frametubular portion 65. For embodiments in which frame 60 includes ring 66,each ventricular anchor support 50 is coupled to the ring (or defined byframe 60) at a respective trough 62.

In the embodiment shown, the peaks and troughs are defined by ring 66having a generally zig-zag shape. However, the scope of the disclosureincludes ring 66 having another shape that defines peaks and troughs,such as a serpentine or sinusoid shape.

In some embodiments, inner frame tubular portion 32 and outer frametubular portion 65 may form annular valve body 25. Annular valve body 25may circumscribe axis ax1, and atrial anchoring arms 46 and ventricularanchoring legs 54 may extend from annular valve body 25. Annular valvebody 25 may have an atrial end, a ventricular end, and an intermediateportion extending between the atrial end and the ventricular end. Forexample, in embodiments depicted in FIG. 1A, atrial end 34 andventricular end 36 of inner frame tubular portion 32 may constitute theatrial and ventricular ends of annular valve body 25, respectively.According to such embodiments, the intermediate portion of annular valvebody 25 may include portions of annular valve body 25 positioned betweenatrial end 34 and ventricular end 36. However, one of ordinary skillwill understand that this embodiment is merely exemplary, and that otherportions of annular valve body 25 may form the atrial and ventricularends of annular valve body 25. In some embodiments, and as illustratedin FIGS. 1A and 2E, inner frame 30 may extend upstream in an atrialdirection beyond the atrial end 67 of outer frame 60.

For embodiments in which frame assembly 22 has a plurality of couplingpoints 52, the coupling points (and therefore coupling elements 31 and61) are disposed circumferentially around the frame assembly (e.g.,around axis ax1), in some embodiments on a transverse plane that isorthogonal to axis ax1. This transverse plane is illustrated by theposition of section A-A in FIG. 2B. Alternatively, coupling points 52may be disposed at different longitudinal heights of frame assembly 22,e.g., such that different ventricular anchoring legs 54 are positionedand/or moved differently to others. In some embodiments, coupling points52 (and therefore coupling elements 31 and 61) are disposedlongitudinally between atrial end 24 and ventricular end 26 of frameassembly 22, but not at either of these ends. Further in someembodiments, coupling points 52 are disposed longitudinally betweenatrial end 34 and ventricular end 36 of inner frame tubular portion 32,but not at either atrial end 34 or ventricular end 36. For example, thecoupling points may be more than 3 mm (e.g., 4-10 mm) both from atrialend 34 and from ventricular end 36. It is hypothesized that thisadvantageously positions the coupling points at a part of inner frametubular portion 32 that is more rigid than atrial end 34 or ventricularend 36.

It is to be noted that ventricular anchor support 50 may be expandableinto its unconstrained configuration (e.g., a released-leg state) suchthat ventricular anchoring leg 54 extends away from axis ax1,independently of increasing the diameter of inner frame tubular portion32 and outer frame tubular portion 65 (e.g., as shown in FIGS. 2B & 2D).Similarly, upstream support portion 40 may be expandable into itsunconstrained configuration (e.g., a released-arm state) such that it(e.g., atrial anchoring arms 46 thereof) extends away from axis ax1,independently of increasing the diameter of inner frame tubular portion32 and outer frame tubular portion 65 (e.g., as shown in FIGS. 2C & 2D).The state shown in FIG. 2D may be considered to be an intermediatestate. Therefore, prosthetic valve 20 may be configured such thatventricular anchor supports 50 (e.g., ventricular anchoring legs 54thereof) and upstream support portion 40 are expandable such that theyboth extend away from axis ax1, while retaining a distance d3therebetween. This distance is subsequently reducible to a distance d4by expanding inner frame tubular portion 32 and outer frame tubularportion 65 (e.g., shown in FIG. 2E).

For some embodiments, while inner frame tubular portion 32 remains inits contracted delivery configuration, ventricular anchoring leg 54 canextend away from axis ax1 over 40 percent (e.g., 40-80 percent, such as40-70 percent) of the distance that it extends from the axis subsequentto the expansion of the inner frame tubular portion. For example, forembodiments in which prosthetic valve 20 includes a ventricularanchoring leg on opposing sides of the prosthetic valve, a span d15 ofthe ventricular anchoring legs while inner frame tubular portion 32 isin its contracted delivery configuration may be at least 40 percent(e.g., 40-80 percent, such as 40-70 percent) as great as a span d16 ofthe ventricular anchoring legs subsequent to the expansion of the innerframe tubular portion. For some embodiments, span d15 is greater than 15mm and/or less than 50 mm (e.g., 20-30 mm). For some embodiments, spand16 is greater than 30 mm and/or less than 60 mm (e.g., 40-50 mm). It isto be noted that ventricular anchoring leg 54 is effectively fullyexpanded, with respect to other portions of ventricular anchor support50 and/or with respect to inner frame tubular portion 32, before andafter the expansion of the inner frame tubular portion.

Similarly, for some embodiments, while inner frame tubular portion 32remains in its contracted delivery configuration, upstream supportportion 40 (e.g., atrial anchoring arms 46) can extend away from axisax1 over 30 percent (e.g., 30-70 percent) of the distance that itextends from the axis subsequent to the expansion of the inner frametubular portion. That is, for some embodiments, a span d17 of theupstream support portion while inner frame tubular portion 32 is in itscontracted delivery configuration may be at least 30 percent (e.g.,30-70 percent) as great as a span d18 of the upstream support portionsubsequent to the expansion of the inner frame tubular portion. For someembodiments, span d17 is greater than 16 mm (e.g., greater than 20 mm)and/or less than 50 mm (e.g., 30-40 mm). For some embodiments, span d18is greater than 40 mm and/or less than 65 mm (e.g., 45-56 mm, such as45-50 mm). It is to be noted that upstream support portion 40 iseffectively fully expanded, with respect to inner frame tubular portion32, before and after the expansion of the inner frame tubular portion.

It is to be noted that when inner frame tubular portion 32 is expanded,ventricular anchoring legs 54 may translate radially outward from spand15 to span d16 (e.g., without deflecting). In some embodiments upstreamsupport portion 40 behaves similarly (e.g., atrial anchoring arms 46translated radially outward from span d17 to span d18, e.g., withoutdeflecting). That is, an orientation of each ventricular anchoring leg54 and/or each atrial anchoring arm 46 with respect to inner frametubular portion 32 and/or axis ax1 is in some embodiments the same inthe state shown in FIG. 2D as it is in the state shown in FIG. 2E.Similarly, in some embodiments an orientation of each ventricularanchoring leg 54 with respect to upstream support portion 40 (e.g., withrespect to one or more atrial anchoring arms 46 thereof) is the samebefore and after expansion of inner frame tubular portion 32.

For some embodiments, increasing the diameter of inner frame tubularportion 32 from d1 to d2 causes greater than 1 mm and/or less than 20 mm(e.g., 1-20 mm, such as 1-10 mm or 5-20 mm) of longitudinal movement ofventricular anchoring leg 54 away from coupling point 52. For someembodiments, increasing the diameter of inner frame tubular portion 32from d1 to d2 causes greater than 1 mm and/or less than 20 mm (e.g.,1-20 mm, such as 1-10 mm or 5-20 mm) of longitudinal movement ofupstream support portion 40 toward coupling point 52. For someembodiments, distance d3 is 7-30 mm. For some embodiments, distance d4is 0-15 mm (e.g., 2-15 mm). For some embodiments, increasing thediameter of inner frame tubular portion 32 from d1 to d2 reduces thedistance between the upstream support portion and ventricular anchoringlegs 54 by more than 5 mm and/or less than 30 mm, such as 5-30 mm (e.g.,10-30 mm, such as 10-20 mm or 20-30 mm). For some embodiments, thedifference between d3 and d4 is generally equal to the differencebetween d1 and d2. For some embodiments, the difference between d3 andd4 is more than 1.2 and/or less than 3 times (e.g., 1.5-2.5 times, suchas about 2 times) greater than the difference between d1 and d2.

For some embodiments, ventricular anchoring legs 54 curve such that aterminal end 55 of each ventricular anchoring leg 54 is disposed at ashallower angle with respect to inner region 42 of upstream supportportion 40, than are portions of ventricular anchor support 50 that arecloser to ventricular end 26 of frame assembly 22. For some suchembodiments, a terminal end 55 of each ventricular anchoring leg 54 maybe generally parallel with inner region 42. For some such embodiments,while inner frame tubular portion 32 is in its unconstrainedconfiguration, a terminal end 55 of each ventricular anchoring leg 54that extends from the terminal end of the ventricular anchoring leg 54at least 2 mm along the ventricular anchoring leg 54, is disposed within2 mm of upstream support portion 40. Thus, for some embodiments, whileinner frame tubular portion 32 is in its unconstrained configuration,for at least 5 percent (e.g., 5-8 percent, or at least 8 percent) ofspan 18 of upstream support portion 40, the upstream support portion isdisposed within 2 mm of a ventricular anchoring leg 54.

For some embodiments, in the absence of any obstruction (such as tissueof the valve or covering 23) between ventricular anchoring leg 54 andupstream support portion 40, increasing the diameter of inner frametubular portion 32 from d1 to d2 causes the ventricular anchoring legand the upstream support portion to move past each other (e.g., theventricular anchoring leg 54 may move between atrial anchoring arms 46of the upstream support portion), such that the ventricular anchoringleg 54 is closer to the atrial end of prosthetic valve 20 than is theupstream support portion, e.g., as shown hereinbelow for frameassemblies 122 and 222, mutatis mutandis. (For embodiments in whichupstream support portion 40 is covered by covering 23, ventricularanchoring legs 54 may not pass the covering. For example, in the absenceof any obstruction, ventricular anchoring legs 54 may pass betweenatrial anchoring arms 46, and press directly against covering 23.) It ishypothesized that in some embodiments this configuration applies greaterforce to the valve tissue being sandwiched, and thereby furtherfacilitates anchoring of the prosthetic valve. That is, for someembodiments, distance d3 is smaller than the sum of distance d5 and adistance d14 (described with reference to FIG. 3C). For someembodiments, increasing the diameter of inner frame tubular portion 32from d1 to d2 advantageously causes ventricular anchoring legs 54 andupstream support portion 40 to move greater than 3 mm and/or less than25 mm (e.g., greater than 5 mm and/or less than 15 mm, e.g., 5-10 mm,such as about 7 mm) with respect to each other (e.g., toward each otherand then past each other).

For some embodiments, in the unconstrained configuration of frameassembly 22, upstream support portion 40 has an inner region (e.g., aninner ring) 42 that extends radially outward at a first angle withrespect to axis ax1 (and in some embodiments with respect to inner frametubular portion 32), and an outer region (e.g., an outer ring) 44 thatextends, from the inner region, further radially outward from the innerframe tubular portion 32 at a second angle with respect to the innerframe tubular portion 32, the second angle being smaller than the firstangle. For example, in some embodiments inner region 42 extends radiallyoutward at an angle alpha_1 of 60-120 degrees (e.g., 70-110 degrees)with respect to axis ax1, and outer region 44 extends radially outwardat an angle alpha_2 of 5-70 degrees (e.g., 10-60 degrees) with respectto axis ax1.

It is to be noted that angles alpha_1 and alpha_2 are measured betweenthe respective region support portion 40, and the portion of axis ax1that extends in an upstream, atrial direction from the level of frameassembly 22 at which the respective region begins to extend radiallyoutward.

In some embodiments in which prosthetic valve 20 is configured to beplaced at an atrioventricular valve (e.g., a mitral valve or a tricuspidvalve) of the subject, region 42 is configured to be placed against theupstream surface of the annulus of the atrioventricular valve, andregion 44 is configured to be placed against the walls of the atriumupstream of the valve.

For some embodiments, outer region 44 is more flexible than inner region42. For example, and as shown, each atrial anchoring arm 46 may have adifferent structure in region 44 than in region 42. It is hypothesizedthat the relative rigidity of region 42 provides resistance againstventricular migration of prosthetic valve 20, while the relativeflexibility of region 44 facilitates conformation of upstream supportportion 40 to the atrial anatomy.

For some embodiments, two or more of atrial anchoring arms 46 areconnected by a connector (not shown), reducing the flexibility, and/orthe independence of movement of the connected atrial anchoring armsrelative to each other. For some embodiments, atrial anchoring arms 46are connected in particular sectors of upstream support portion 40,thereby making these sectors more rigid than sectors in which the atrialanchoring arms 46 are not connected. For example, a relatively rigidsector may be provided to be placed against the posterior portion of themitral annulus, and a relatively flexible sector may be provided to beplaced against the anterior side of the mitral annulus, so as to reduceforces applied by upstream support portion 40 on the aortic sinus.

For some embodiments, and as shown, coupling points 52 are disposedcloser to ventricular end 26 of frame assembly 22 than are ventricularanchoring legs 54, or is upstream support portion 40.

As described in more detail with respect to FIGS. 4A-F, the movement ofventricular anchoring leg 54 away from coupling point 52 (and movementof upstream support portion 40 toward the coupling point) facilitatesthe sandwiching of tissue of the native valve (e.g., leaflet and/orannulus tissue) between the ventricular anchoring leg and the upstreamsupport portion, thereby securing prosthetic valve 20 at the nativevalve.

In some embodiments, in the contracted delivery configuration of innerframe tubular portion 32, a ventricular end of each ventricular anchorsupport 50 is longitudinally closer than valve-frame coupling elements31 to ventricular end 36, and ventricular anchoring leg 54 of eachventricular anchor support 40 is disposed longitudinally closer than thevalve-frame coupling elements to atrial end 34. In some embodiments,this is also the case in the unconstrained configuration of inner frametubular portion 32.

FIGS. 3A-C show structural changes in frame assembly 22 duringtransitioning of the assembly between its contracted deliveryconfiguration and unconstrained configuration, in accordance with someembodiments of the disclosure. FIGS. 3A-C each show a portion of theframe assembly, the structural changes thereof being representative ofthe structural changes that occur in other portions of the frameassembly. FIG. 3A shows a ventricular anchor support 50 and struts 70(e.g., a portion of outer frame 60), and illustrates the structuralchanges that occur around outer frame 60. FIG. 3B shows a portion ofinner frame 30, and illustrates the structural changes that occur aroundthe inner frame. FIG. 3C shows inner frame 30 as a whole. In each ofFIGS. 3A-C, state (A) illustrates the structure while frame assembly 22(and in particular inner frame tubular portion 32) is in its contracteddelivery configuration, and state (B) illustrates the structure whilethe frame assembly (and in particular inner frame tubular portion 32) isin its unconstrained configuration.

FIG. 3A shows structural changes in the coupling of ventricular anchorsupports 50 to coupling point 52 (e.g., structural changes of outerframe 60) during the transitioning of frame assembly 22 (and inparticular inner frame tubular portion 32) between its contracteddelivery configuration and unconstrained configuration. Each ventricularanchor support 50 is coupled to inner frame 30 via at least one strut70, which connects the ventricular anchor support 50 to coupling point52. In some embodiments, each ventricular anchor support 50 is coupledto inner frame 30 via a plurality of struts 70. A first end 72 of eachstrut 70 is coupled to ventricular anchor support 50, and a second end74 of each strut is coupled to a coupling point 52. As describedhereinabove, for embodiments in which frame 60 includes ring 66, eachventricular anchor support 50 is coupled to the ring at a respectivetrough 62. Ring 66 may include struts 70, extending between the peaksand troughs, with each first end 72 at (or close to) a trough 62, andeach second end 74 at (or close to) a peak 64.

In the contracted delivery configuration of frame assembly 22 (and inparticular of inner frame tubular portion 32), each strut 70 is disposedat a first angle in which first end 72 is disposed closer than secondend 74 to the ventricular end of the frame assembly. Expansion of frameassembly 22 (and in particular of inner frame tubular portion 32) towardits unconstrained configuration causes strut 70 to deflect to a secondangle. This deflection moves first end 72 away from the ventricular endof frame assembly 22. That is, in the unconstrained configuration offrame assembly 22, first end 72 is further from the ventricular end ofthe frame assembly than it is when the frame assembly is in itscontracted delivery configuration. This movement is shown as a distanced5 between the position of end 72 in state (A) and its position in state(B). This movement causes the above-described movement of ventricularanchoring legs 54 away from coupling points 52. As shown, ventricularanchoring legs 54 may move the same distance d5 in response to expansionof frame assembly 22.

For embodiments in which outer frame 60 includes ring 66, the pattern ofalternating peaks and troughs may be described as having an amplitudelongitudinally between the peaks and troughs, i.e., measured parallelwith central longitudinal axis ax1 of frame assembly 22, and thetransition between the contracted delivery configuration andunconstrained configuration may be described as follows: In thecontracted delivery configuration of frame assembly 22 (and inparticular of inner frame tubular portion 32), the pattern of ring 66has an amplitude d20. In the unconstrained configuration, frame assembly22 (and in particular of inner frame tubular portion 32), the pattern ofring 66 has an amplitude d21 that is lower than amplitude d20. Becauseit is at peaks 64 that ring 66 is coupled to inner frame 30 at couplingpoints 52, and it is at troughs 62 that ring 66 is coupled toventricular anchor supports 50, this reduction in the amplitude of thepattern of ring 66 moves ventricular anchor supports 50 (e.g.,ventricular anchoring legs 54 thereof) longitudinally further from theventricular end of the frame assembly. The magnitude of thislongitudinal movement (e.g., the difference between magnitudes d20 andd21) is equal to d5.

In some embodiments, distance d5 is the same distance as the distancethat ventricular anchoring leg 54 moves away from coupling point 52during expansion of the frame assembly. That is, a distance betweenventricular anchoring leg 54 and the portion of ventricular anchorsupport 50 that is coupled to strut 70, in some embodiments remainsconstant during expansion of the frame assembly. For some embodiments,the longitudinal movement of ventricular anchoring leg 54 away fromcoupling point 52 is a translational movement (e.g., a movement thatdoes not include rotation or deflection of the ventricular anchoring leg54).

For some embodiments, a distance d6, measured parallel to axis ax1 offrame assembly 22, between coupling point 52 and first end 72 of strut70 while assembly 22 is in its contracted delivery configuration, is3-15 mm. For some embodiments, a distance d7, measured parallel to axisax1, between coupling point 52 and first end 72 of strut 70 whileassembly 22 is in its unconstrained configuration, is 1-5 mm (e.g., 1-4mm).

For some embodiments, amplitude d20 is 2-10 mm (e.g., 4-7 mm). For someembodiments, amplitude d21 is 4-9 mm (e.g., 5-7 mm).

For some embodiments, and as shown, in the unconstrained configuration,first end 72 of strut 70 is disposed closer to the ventricular end offrame assembly 22 than is coupling point 52. For some embodiments, inthe unconstrained configuration, first end 72 of strut 70 is disposedfurther from the ventricular end of frame assembly 22 than is couplingpoint 52.

For embodiments in which frame assembly 22 includes a plurality ofventricular anchor supports 50 and a plurality of coupling points 52(e.g., for embodiments in which the frame assembly includes outer frame60) expansion of the frame assembly increases a circumferential distancebetween adjacent coupling points 52, and an increase in acircumferential distance between adjacent ventricular anchor supports50. FIG. 3A shows such an increase in the circumferential distancebetween adjacent coupling points 52, from a circumferential distance d8in the contracted delivery configuration to a circumferential distanced9 in the unconstrained configuration. For some embodiments, distance d8is 1-6 mm. For some embodiments, distance d9 is 3-15 mm.

For some embodiments, in addition to being coupled via ring 66 (e.g.,struts 70 thereof) ventricular anchor supports 50 are also connected toeach other via connectors 78. Connectors 78 allow the described movementof ventricular anchor supports 50 during expansion of frame assembly 22,but may stabilize ventricular anchor supports 50 relative to each otherwhile the frame assembly is in its unconstrained configuration. Forexample, connectors 78 may bend and/or deflect during expansion of theframe assembly.

FIGS. 3B-C show structural changes in inner frame 30 during thetransitioning of frame assembly 22 between its contracted deliveryconfiguration and unconstrained configuration. Inner frame tubularportion 32 of inner frame 30 is defined by a plurality of cells 80,which are defined by the repeating pattern of the inner frame. Whenframe assembly 22 is expanded from its contracted delivery configurationtoward its unconstrained configuration, cells 80 widen from a width d10to a width d11 (measured orthogonal to axis ax1 of the frame assembly),and shorten from a height d12 to a height d13 (measured parallel to axisax1 of the frame assembly). This shortening reduces the overall height(i.e., a longitudinal length between atrial end 34 and ventricular end36) of inner frame tubular portion 32 from a height d22 to a height d23,and thereby causes the above-described longitudinal movement of upstreamsupport portion 40 toward coupling points 52 by a distance d14 (shown inFIG. 30). For some embodiments, and as shown, coupling points 52 aredisposed at the widest part of each cell.

Due to the configurations described herein, the distance by whichventricular anchoring legs 54 move with respect to (e.g., toward, ortoward-and-beyond) upstream support portion 40 (e.g., atrial anchoringarms 46 thereof), may be greater than the reduction in the overallheight of inner frame tubular portion 32 (e.g., more than 20 percentgreater, such as more than 30 percent greater, such as more than 40percent greater). That is, prosthetic valve 20 includes an inner frame30 that includes an inner frame tubular portion 32 that circumscribes alongitudinal axis ax1 of the inner frame so as to define a lumen 38along the axis, the inner frame tubular portion 32 having an atrial end34, a ventricular end 36, a longitudinal length therebetween, and adiameter (e.g., d1 or d2) transverse to the longitudinal axis; a valvemember 58, coupled to the inner frame tubular portion 32, disposedwithin the lumen, and arranged to provide unidirectionalupstream-to-downstream (i.e. atrial-to-ventricular) flow of bloodthrough the lumen; an upstream support portion 40, coupled to the innerframe tubular portion 32; and an outer frame 60, coupled to the innerframe tubular portion 32, and including a ventricular anchoring leg 54,wherein the prosthetic valve 20 has a first state (e.g., as shown inFIG. 2D and FIG. 4D) and a second state (e.g., as shown in FIG. 2E andFIG. 4E), in both the first state and the second state, the upstreamsupport portion 40 extends radially outward from the inner frame tubularportion 32, and the ventricular anchoring leg 54 extends radiallyoutward from the inner frame tubular portion 32, and the inner frametubular portion 32, the upstream support portion 40, and the outer frame60 are arranged such that transitioning of the prosthetic valve 20 fromthe first state toward the second state increases the diameter of theinner frame tubular portion 32 by a diameter-increase amount (e.g., thedifference between d1 and d2), decreases the length of the inner frametubular portion 32 by a length-decrease amount (e.g., the differencebetween d22 and d23), and moves the ventricular anchoring leg 54 alongitudinal distance with respect to (e.g., toward ortoward-and-beyond) the upstream support portion 40 (e.g., the differencebetween d3 and d4), this distance being greater than the length-decreaseamount.

As shown in the figures, inner frame 30 may be coupled to outer frame 60by coupling between a valve-frame coupling element 31 defined by innerframe 30, and an outer-frame coupling element 61 defined by outer frame60 (e.g., an outer-frame coupling element is coupled to end 74 of eachstrut). In some embodiments, elements 31 and 61 are fixed with respectto each other. Each coupling point 52 may therefore be defined as thepoint at which a valve-frame coupling element and a correspondingouter-frame coupling element 61 are coupled (e.g., are fixed withrespect to each other). For some embodiments, and as shown, elements 31and 61 are eyelets configured to be coupled together by a connector,such as a pin or suture. For some embodiments, elements 31 and 61 aresoldered or welded together.

In some embodiments, and as shown, valve-frame coupling elements 31 aredefined by inner frame tubular portion 32, and are disposedcircumferentially around central longitudinal axis ax1. Outer-framecoupling elements 61 are coupled to ring 66 (or defined by frame 60,such as by ring 66) at respective peaks 64.

As shown (e.g., in FIGS. 2A-E), inner frame 30 (e.g., inner frametubular portion 32 thereof) and outer frame 60 (e.g., ring 66 thereof)are arranged in a close-fitting coaxial arrangement, in both theunconstrained configuration and contracted delivery configuration offrame assembly 22. Ignoring spaces due to the cellular structure of theframes, a radial gap d19 between inner frame 30 (e.g., inner frametubular portion 32 thereof) and outer frame 60 (e.g., ring 66 thereof)may be less than 2 mm (e.g., less than 1 mm), in both the contracteddelivery configuration and unconstrained configuration, and during thetransition therebetween. This is facilitated by the coupling betweenframes 30 and 60, and the behavior, described hereinabove, of frame 60in response to changes in the diameter of inner frame tubular portion 32(e.g., rather than solely due to delivery techniques and/or tools). Forsome embodiments, more than 50 percent (e.g., more than 60 percent) ofring 66 is disposed within 2 mm of inner frame tubular portion 32 inboth the contracted delivery configuration and unconstrainedconfiguration, and during the transition therebetween. For someembodiments, more than 50 percent (e.g., more than 60 percent) of outerframe 60, except for ventricular anchoring legs 54, is disposed within 2mm of inner frame tubular portion 32 in both the contracted deliveryconfiguration and unconstrained configuration, and during the transitiontherebetween. As illustrated in FIGS. 2A and 20, ventricular anchoringlegs 54 may be substantially flush with inner frame 30 when in thecontracted delivery configuration. This may be, at least in part, due tothe small distance d19 (illustrated in FIG. 2D) between inner frame 30and outer frame 60, and due to the fact that ventricular anchoring legs54 are arranged parallel with axis ax1 when in the contracted deliveryconfiguration (as explained above).

The structural changes to frame assembly 22 (e.g., to outer frame 60thereof) are described hereinabove as they occur during (e.g., as aresult of) expansion of the frame assembly (in particular inner frametubular portion 32 thereof). This is the natural way to describe thesechanges because, as described hereinbelow with respect to FIGS. 4A-6,frame assembly 22 is in its contracted delivery configuration duringpercutaneous delivery to the implant site, and is subsequently expanded.However, the nature of prosthetic valve 20 may be further understood bydescribing structural changes that occur during compression of the frameassembly 22 (e.g., a transition from the unconstrained configuration inFIG. 2E to the intermediate state in FIG. 2D), in particular inner frametubular portion 32 thereof (including if inner frame tubular portion 32were compressed by application of compressive force to the inner frametubular portion 32, and not to frame 60 except via the inner frametubular portion 32 pulling frame 60 radially inward). Such descriptionsmay also be relevant because prosthetic valve 20 may be compressed(i.e., “crimped”) soon before its percutaneous delivery, and thereforethese changes may occur while prosthetic valve 20 is in the care of theoperating physician.

For some embodiments, the fixation of peaks 64 to respective sites ofinner frame tubular portion 32 is such that compression of the innerframe tubular portion 32 from its unconstrained configuration toward itscontracted delivery configuration such that the respective sites of theinner frame tubular portion 32 pull the peaks radially inward viaradially-inward tension on coupling points 52 reduces a circumferentialdistance between each coupling point 52 and its adjacent coupling points52 (e.g., from d9 to d8), and increases the amplitude of the pattern ofring 66 (e.g., from d21 to d20).

For some embodiments, the fixation of outer-frame coupling elements 61to valve-frame coupling elements 31 is such that compression of innerframe tubular portion 32 from its unconstrained configuration toward itscontracted delivery configuration such that the valve-frame couplingelements 31 pull the outer-frame coupling elements 61 radially inwardreduces a circumferential distance between each outer-frame couplingelement 61 and its adjacent outer-frame coupling elements 61 (e.g., fromd9 to d8), and increases the amplitude of the pattern of ring 66 (e.g.,from d21 to d20).

For some embodiments, the fixation of peaks 64 to the respective sitesof inner frame tubular portion 32 is such that compression of the innerframe tubular portion 32 from its unconstrained configuration toward itscontracted delivery configuration pulls the peaks radially inward viaradially-inward pulling of the respective sites of the inner frametubular portion 32 on the peaks, reduces a circumferential distancebetween each of coupling points 52 and its adjacent coupling points 52(e.g., from d9 to d8), and increases the amplitude of the pattern ofring 66 (e.g., from d21 to d20), without increasing radial gap d19between inner frame 30 (e.g., inner frame tubular portion 32 thereof)and the ring 66 by more than 1.5 mm.

For some embodiments, the fixation of outer-frame coupling elements 61with respect to valve-frame coupling elements 31 is such thatcompression of inner frame tubular portion 32 from its unconstrainedconfiguration toward its contracted delivery configuration pullsouter-frame coupling elements 61 radially inward via radially-inwardpulling of valve-frame coupling elements 31 on outer-frame couplingelements 61, reduces a circumferential distance between each of theouter-frame coupling elements 61 and its adjacent outer-frame couplingelements 61 (e.g., from d9 to d8), and increases the amplitude of thepattern of ring 66 (e.g., from d21 to d20), without increasing radialgap d19 between inner frame 30 (e.g., inner frame tubular portion 32thereof) and the ring 66 by more than 1.5 mm.

Reference is made to FIGS. 4A-F, which are schematic illustrations ofimplantation of prosthetic valve 20 at a native valve 10 of a heart 4 ofa subject, in accordance with some embodiments of the disclosure. Valve10 is shown as a mitral valve of the subject, disposed between a leftatrium 6 and a left ventricle 8 of the subject. However prosthetic valve20 may be implanted at another heart valve of the subject, mutatismutandis. Similarly, although FIGS. 4A-F show prosthetic valve 20 beingdelivered transseptally via a sheath 88, the prosthetic valve 20 mayalternatively be delivered by any other suitable route, such astransatrially, or transapically.

Prosthetic valve 20 is delivered, in its contracted deliveryconfiguration, to native valve 10 using a delivery tool 89 that isoperable from outside the subject (FIG. 4A). In some embodiments,prosthetic valve 20 is delivered within a delivery capsule 90 of tool89, which retains the prosthetic valve 20 in its contracted deliveryconfiguration. A transseptal approach, such as a transfemoral approach,is shown. In some embodiments, prosthetic valve 20 is positioned suchthat at least ventricular anchoring legs 54 are disposed downstream of(that is, in a ventricular direction from) the native valve (i.e.,within ventricle 8). At this stage, frame assembly 22 of prostheticvalve 20 is as shown in FIG. 2A.

Subsequently, ventricular anchoring legs 54 are allowed to protruderadially outward into their unconstrained configuration, as describedhereinabove, e.g., by releasing them from capsule 90 (FIG. 4B), forexample within ventricle 8. For example, and as shown, capsule 90 mayinclude a distal capsule-portion 92 and a proximal capsule-portion 94,and the distal capsule-portion may be moved distally with respect toprosthetic valve 20, so as to expose ventricular anchoring legs 54. Atthis stage, frame assembly 22 of prosthetic valve 20 is as shown in FIG.2B, in which annular valve body 25 and upstream support portion 40remain in their contracted delivery configurations.

Subsequently, prosthetic valve 20 is moved upstream in an atrialdirection, such that upstream support portion 40, in its contracteddelivery configuration, is disposed upstream of (that is, in an atrialdirection from) leaflets 12 (i.e., within atrium 6). For someembodiments, the upstream movement of prosthetic valve 20 causesventricular anchoring legs 54 to engage the ventricular side of leaflets12. However, because of the relatively large distance d3 provided byprosthetic valve 20 (described hereinabove), in some embodiments it maynot be necessary to move the prosthetic valve 20 so far upstream thatventricular anchoring legs 54 tightly engage leaflets 12 and/or pull theleaflets upstream of the valve annulus. Upstream support portion 40 isthen allowed to expand such that it protrudes radially outward into itsunconstrained configuration, as described hereinabove, e.g., byreleasing it from capsule 90 (FIG. 4D), for example within atrium 6. Forexample, and as shown, proximal capsule-portion 94 may be movedproximally with respect to prosthetic valve 20, so as to expose upstreamsupport portion 40. At this stage, frame assembly 22 of prosthetic valve20 is as shown in FIG. 2D, in which distance d3 exists between upstreamsupport portion 40 and ventricular anchoring legs 54, the ventricularanchoring legs have span d15, the upstream support portion has span d17,and (iv) inner frame tubular portion 32 has diameter d1. Put anotherway, annular valve body 25 remains in the contracted deliveryconfiguration.

In some embodiments, expansion of frame assembly 22 is inhibited bydistal capsule-portion 92 (e.g., by inhibiting expansion of inner frametubular portion 32), and/or by another portion of delivery tool 89(e.g., a portion of the delivery tool that is disposed within lumen 38).

Subsequently, prosthetic valve 20 is allowed to expand toward itsunconstrained configuration, as illustrated in FIG. 4E, while upstreamsupport portion 40 is positioned within atrium 6 and ventricularanchoring legs 54 are positioned within ventricle 8. As a result,annular valve frame 25 radially expands and inner frame tubular portion32 widens to diameter d2, and the distance between upstream supportportion 40 and ventricular anchoring legs 54 reduces to distance d4(FIG. 4E). This sandwiches tissue of valve 10 (in some embodimentsincluding annular tissue and/or leaflets 12) between upstream supportportion 40 and ventricular anchoring legs 54, thereby securingprosthetic valve 20 at the valve. FIG. 4F shows delivery capsule 90having been removed from the body of the subject, leaving prostheticvalve 20 in place at valve 10.

As described hereinabove, prosthetic valve 20 is configured such thatwhen inner frame tubular portion 32 is expanded, ventricular anchoringlegs 54 and upstream support portion 40 move a relatively large distancetoward each other. This enables distance d3 to be relatively large,while distance d4 is sufficiently small to provide effective anchoring.As also described hereinabove, prosthetic valve 20 is configured suchthat ventricular anchoring legs 54 and upstream support portion 40 canextend radially outward a relatively large distance while inner frametubular portion 32 remains compressed. It is hypothesized that for someembodiments, these configurations (independently and/or together)facilitate effective anchoring of prosthetic valve 20, by facilitatingplacement of a relatively large proportion of valve tissue (e.g.,leaflets 12) between the ventricular anchoring legs 54 and the upstreamsupport portion prior to expanding inner frame tubular portion 32 andsandwiching the valve tissue.

It is further hypothesized that the relatively great radially-outwardextension of ventricular anchoring legs 54 and upstream support portion40 prior to expansion of inner frame tubular portion 32, furtherfacilitates the anchoring/sandwiching step by reducing radially-outwardpushing of the valve tissue (e.g., leaflets 12) during the expansion ofthe inner frame tubular portion 32, and thereby increasing the amount ofvalve tissue that is sandwiched.

It is yet further hypothesized that this configuration of prostheticvalve 20 facilitates identifying correct positioning of the prostheticvalve 20 (i.e., with upstream support portion 40 upstream of leaflets 12and ventricular anchoring legs 54 downstream of the leaflets) prior toexpanding inner frame tubular portion 32 and sandwiching the valvetissue.

As shown in FIG. 1A, for some embodiments, in the unconstrainedconfiguration of frame assembly 22, prosthetic valve 20 defines atoroidal space 49 between ventricular anchoring legs 54 and upstreamsupport portion 40 (e.g., a space that is wider than distance d4). Forexample, space 49 may have a generally triangular cross-section. It ishypothesized that for some such embodiments, in addition to sandwichingtissue of the native valve between upstream support portion 40 andventricular anchoring legs 54 (e.g., the terminal ends 55 of theventricular anchoring legs 54), space 49 advantageously promotes tissuegrowth therewithin (e.g., between leaflet tissue and covering 23), whichover time further secures prosthetic valve 20 within the native valve10.

Reference is now made to FIG. 5, which is a schematic illustration of astep in the implantation of prosthetic valve 20, in accordance with someembodiments of the disclosure. Whereas FIGS. 4A-F show an implantationtechnique in which ventricular anchoring legs 54 are expanded prior toupstream support portion 40, in some embodiments the upstream supportportion is expanded prior to the ventricular anchoring legs 54. FIG. 5shows a step in such an application.

Reference is again made to FIGS. 2A-5. As noted hereinabove, prostheticvalve 20 may be implanted by causing ventricular anchoring legs 54 toradially protrude before causing upstream support portion 40 to radiallyprotrude, or may be implanted by causing the upstream support portion toprotrude before causing the ventricular anchoring legs 54 to protrude.For some embodiments, prosthetic valve 20 is thereby configured to bedeliverable in a downstream, ventricular direction (e.g., transseptally,as shown, or transapically) or in an upstream, atrial direction (e.g.,transapically or via the aortic valve). Thus, for some embodiments, anoperating physician may decide which delivery route is preferable for agiven application (e.g., for a given subject, and/or based on availableequipment and/or expertise), and prosthetic valve 20 is responsivelyprepared for the chosen delivery route (e.g., by loading the prostheticvalve into an appropriate delivery tool).

It is to be noted that for some embodiments, downstream delivery ofprosthetic valve 20 may be performed by expanding ventricular anchoringlegs 54 first (e.g., as shown in FIGS. 4A-F) or by expanding upstreamsupport portion 40 first (e.g., as shown in FIG. 5). Similarly, in someembodiments upstream delivery of prosthetic valve 20 may be performed byupstream support portion 40 first, or by expanding ventricular anchoringlegs 54 first.

Reference is now made to FIG. 6, which is a schematic illustration ofprosthetic valve 20, in the state and position shown in FIG. 4D, inaccordance with some embodiments of the disclosure. For someembodiments, while prosthetic valve 20 is in the state and positionshown in FIG. 4D, leaflets 12 of valve 10 are able to move, at least inpart in response to beating of the heart. Frame (A) shows leaflets 12during ventricular systole, in which the atrial side 12 a of theleaflets 12 may contact the unconstrained atrial anchoring arms 46.Frame (B) shows the leaflets during ventricular diastole, in which theventricular side 12 v of the leaflets 12 may contact the unconstrainedventricular anchoring legs 54. For some such embodiments, blood isthereby able to flow from atrium 6 to ventricle 8, between leaflets 12and prosthetic valve 20. It is hypothesized that this advantageouslyfacilitates a more relaxed implantation procedure, e.g., facilitatingretaining of prosthetic valve 20 in this state and position for aduration of greater than 8 minutes. During this time, imaging techniquesmay be used to verify the position of prosthetic valve 20, and/orpositioning of leaflets 12 between upstream support portion 40 andventricular anchoring legs 54.

Reference is made to FIGS. 7A-B and 8A-B, which are schematicillustrations of frame assemblies 122 and 222 of respective prostheticvalves, in accordance with some embodiments of the disclosure. Exceptwhere noted otherwise, frame assemblies 122 and 222 may be identical toframe assembly 22, mutatis mutandis. Elements of frame assemblies 122and 222 share the name of corresponding elements of frame assembly 22.Additionally, except where noted otherwise, the prosthetic valves towhich frame assemblies 122 and 222 belong are similar to prostheticvalve 20, mutatis mutandis.

Frame assembly 122 includes an inner frame 130 that includes an innerframe tubular portion 132 and an upstream support portion 140 that mayinclude a plurality of atrial anchoring arms 146, and an outer frame 160that circumscribes the inner frame, and includes a plurality ofventricular anchor supports 150 that each include a ventricularanchoring leg 154. In some embodiments, outer frame 160 includes a ring166 to which ventricular anchor supports 150 are coupled. Ring 166 isdefined by a pattern of alternating peaks and troughs, the peaks beingfixed to frame 130 at respective coupling points 152, e.g., as describedhereinabove for frame assembly 22, mutatis mutandis.

Frame assembly 222 includes an inner frame 230 that includes an innerframe tubular portion 232 and an upstream support portion 240 that mayinclude a plurality of atrial anchoring arms 246, and an outer frame 260that circumscribes the inner frame, and includes a plurality ofventricular anchor supports 250 that each include a ventricularanchoring leg 254. In some embodiments, outer frame 260 includes a ring266 to which ventricular anchor supports 250 are coupled. Ring 266 isdefined by a pattern of alternating peaks and troughs, the peaks beingfixed to frame 230 at respective coupling points 252, e.g., as describedhereinabove for frame assembly 22, mutatis mutandis.

Whereas atrial anchoring arms 46 of frame assembly 22 are shown asextending from atrial end 34 of inner frame tubular portion 32, atrialanchoring arms 146 and 246 of frame assemblies 122 and 222,respectively, extend from sites further downstream. (This difference mayalso be made to frame assembly 22, mutatis mutandis.) Inner frametubular portions 32, 132 and 232 are each defined by a repeating patternof cells that extends around the central longitudinal axis. In someembodiments, and as shown, inner frame tubular portions 32, 132 and 232are each defined by two stacked, tessellating rows of cells. In theunconstrained configuration of each inner frame tubular portion, thesecells may be narrower at their atrial and ventricular extremities thanmidway between these extremities. For example, and as shown, the cellsmay be roughly diamond or asteroid in shape. In frame assembly 22, eachatrial anchoring arm 46 is attached to and extends from a site 35 thatis at the atrial extremity of cells of the atrial row. In contrast, inframe assemblies 122 and 222, each atrial anchoring arm 146 or 246 isattached to and extends from a site 135 (assembly 122) or 235 (assembly222) that is at the connection between two adjacent cells of the atrialrow (alternatively described as being at the atrial extremity of cellsof the ventricular row).

It is hypothesized by the inventors that this lower (that is, furtherdownstream) position of the atrial anchoring arms 146, 246, whilemaintaining the length of the lumen of the inner frame tubular portion132, 232, advantageously reduces the distance that the inner frametubular portion 132, 232 (i.e., the ventricular end thereof) extendsinto the ventricle of the subject, and thereby reduces a likelihood ofinhibiting blood flow out of the ventricle through the left ventricularoutflow tract. It is further hypothesized that this position of theatrial anchoring arms 146, 246 reduces radial compression of the innerframe tubular portion 132, 232 by movement of the heart, due to greaterrigidity of the inner frame tubular portion 132, 232 at sites 135 and235 (which is supported by two adjacent cells) than at site 35 (which issupported by only one cell).

As shown, in the unconstrained configuration of frame assemblies 22, 122and 222, the ventricular anchor supports (50, 150 and 250, respectively)are circumferentially staggered with the atrial anchoring arms of theupstream support portion (46, 146 and 246, respectively). This allowsthe ventricular anchor supports to move in an upstream, atrial directionbetween the atrial anchoring arms during expansion of the inner frametubular portion (32, 132 and 232, respectively), facilitatingapplication of greater sandwiching force on tissue of the native valve.The lower position of the atrial anchoring arms of assemblies 122 and222 includes circumferentially shifting the position of the atrialanchoring arms by the width of half a cell. In order to maintain thecircumferential staggering of the atrial anchoring arms and ventricularanchor supports, rings 166 and 266 (and thereby ventricular anchorsupports 150 and 250) are circumferentially shifted correspondingly. Asa result, whereas the peaks of ring 66 generally align with connectionsbetween adjacent cells of the ventricular row of cells of inner frametubular portion 32 (and are fixed to these sites), the peaks of rings166 and 266 are generally aligned midway between these sites (i.e., atspaces of the cellular structure of the inner frame tubular portion). Anappendages 168 (for assembly 122) or 268 (for assembly 222) facilitatefixing of the peak with respect to the tubular structure.

For assembly 122, appendages 168 are defined by inner frame 130 (e.g.,by inner frame tubular portion 132 thereof) and extend (in a downstreamdirection) to the peaks of ring 166, to which they are fixed. Forexample, each appendage 168 may define a valve-frame coupling element131 that is fixed to a respective outer-frame coupling element 161defined by outer frame 260. In some embodiments, appendages 168 extendfrom sites 135. In some embodiments, appendages 168 are integral withinner frame tubular portion 132 and/or in-plane with the inner frametubular portion (e.g., are part of its tubular shape).

For assembly 222, appendages 268 are defined by outer frame 260, andextend (e.g., in an upstream, atrial direction) from the peaks of ring266. In some embodiments, appendages 268 extend to sites 235, to whichthey are fixed. For example, each appendage 268 may define anouter-frame coupling element 261 that is fixed to a respectivevalve-frame coupling element 231 defined by inner frame 230 (e.g., byinner frame tubular portion 232 thereof). In some embodiments,appendages 268 are integral with outer frame 260 and/or in-plane withadjacent portions of outer frame 260, such as ring 266.

Therefore, frame assembly 122 defines a hub at site 135, and frameassembly 222 defines a hub at site 235. For some embodiments, apparatustherefore includes a plurality of prosthetic valve leaflets; and a frameassembly, including an inner frame tubular portion 132, 232 defined by arepeating pattern of cells, the inner frame tubular portion extendingcircumferentially around longitudinal axis ax1 so as to define alongitudinal lumen, the prosthetic valve leaflets coupled to the innerframe and disposed within the lumen; an outer frame 160, 260 including aplurality of ventricular anchor supports 150, 250 distributedcircumferentially around the inner frame tubular portion, eachventricular anchor support 50 having a ventricular anchoring leg 154,254; an upstream support portion 140, 240 that includes a plurality ofatrial anchoring arms 146, 246 that extend radially outward from theinner frame tubular portion; and a plurality of appendages 168, 268,each having a first end that defines a coupling element 161, 261 viawhich the inner frame tubular portion is coupled to the outer frame, anda second end; wherein the frame assembly defines a plurality of hubs135, 235 distributed circumferentially around the longitudinal axis on aplane that is transverse to longitudinal axis ax1, each hub defined byconvergence and connection of, two adjacent cells of the inner frametubular portion, an atrial anchoring arm of the plurality of atrialanchoring arms, and an appendage of the plurality of appendages.

Reference is made to FIGS. 9A-C, which are schematic illustrations of aprosthetic valve 320 including a frame assembly 322, in accordance withsome embodiments of the disclosure. Except where noted otherwise, frameassembly 322 is identical to frame assembly 122, and prosthetic valve300 is identical to the prosthetic valve to which frame assembly 122belongs, mutatis mutandis. FIG. 9A is a side-view of prosthetic valve320, and FIG. 9B is an isometric bottom-view of the prosthetic valve.

Frame assembly 122 includes an inner frame 330 that includes an innerframe tubular portion 332 and an upstream support portion 340 that mayinclude a plurality of atrial anchoring arms 346, and an outer frame 360that circumscribes the inner frame, and includes a plurality ofventricular anchor supports 350 that each include a ventricularanchoring leg 354. In some embodiments, outer frame 360 includes a ring366 to which ventricular anchor supports 350 are coupled. Ring 366 isdefined by a pattern of alternating peaks and troughs, the peaks beingfixed to frame 330 at respective coupling points 352, e.g., as describedhereinabove for frame assembly 22 and/or frame assembly 122, mutatismutandis.

Frame assembly 322 includes an annular upstream support portion 340 thathas an inner portion 342 that extends radially outward from the upstreamportion (e.g., the atrial end) of inner frame tubular portion 332.Upstream support portion 340 further includes one or more fabric pockets344 disposed circumferentially around inner portion 342, each pocket ofthe one or more pockets having an opening that faces a downstream,ventricular direction (i.e., generally toward the ventricular end ofprosthetic valve 320). In the figures, upstream support portion 340 hasa single toroidal pocket 344 that extends circumferentially around innerportion 342.

In some embodiments, a covering 323 (e.g., similar to covering 23,described hereinabove, mutatis mutandis) is disposed over atrialanchoring arms 346, thereby forming pocket 344. Further in someembodiments, atrial anchoring arms 346 are shaped to form pocket 344from covering 323. For example, and as shown, atrial anchoring arms 346may curve to form a hook-shape.

For some embodiments, portion 340 has a plurality of separate pockets344, e.g., separated at atrial anchoring arms 346. For some suchembodiments, covering 323 is loosely-fitted (e.g., baggy) betweenradially-outward parts of atrial anchoring arms 346, e.g., compared toinner portion 342, in which the covering is more closely-fitted betweenradially-inward parts of the atrial anchoring arms.

FIG. 9C shows prosthetic valve 320 implanted at native valve 10. Pocket344 is in some embodiments shaped and arranged to billow in response toperivalvular flow 302 of blood in an upstream, atrial direction. Ifventricular systole forces blood in ventricle 8 between prosthetic valve320 and native valve 10, that blood inflates pocket 344 and presses it(e.g., covering 323 and/or the radially-outward part of atrial anchoringarm 346) against tissue of atrium 6 (e.g., against the atrial wall),thereby increasing sealing responsively. It is hypothesized by theinventors that the shape and orientation of pocket 344 (e.g., thehook-shape of atrial anchoring arms 346) facilitates this pressingradially-outward in response to the pocket's receipt of upstream-flowingblood.

Pocket(s) 344 may be used in combination with any of the prostheticvalves described herein, mutatis mutandis.

Reference is again made to FIGS. 1A-90. It is to be noted that unlessspecifically stated otherwise, the term “radially outward” (e.g., usedto describe upstream support portion 40 and ventricular anchoring legs54) means portions of the element are disposed progressively furtheroutward from a central point (such as longitudinal axis ax1 or innerframe tubular portion 32), but does not necessarily mean disposed at 90degrees with respect to longitudinal axis ax1. For example, ventricularanchoring legs 54 may extend radially outward at 90 degrees with respectto longitudinal axis ax1, but may alternatively extend radially outwardat a shallower angle with respect to the longitudinal axis.

It will be appreciated by persons skilled in the art that the presentdisclosure is not limited to what has been particularly shown anddescribed hereinabove. Rather, the scope of the present disclosureincludes both combinations and subcombinations of the various featuresdescribed hereinabove, as well as variations and modifications thereofthat are not in the prior art, which would occur to persons skilled inthe art upon reading the foregoing description.

The invention claimed is:
 1. A method of implanting a prosthetic valvewithin a native mitral valve, the method comprising: delivering theprosthetic valve into a heart chamber while the prosthetic valve isconstrained in a radially-contracted delivery configuration, wherein theprosthetic valve includes: an annular valve body comprising an annularouter frame and an inner frame situated at least partially within theouter frame, a plurality of ventricular anchors configured to extendfrom the outer frame, and a plurality of atrial anchors configured toextend from the inner frame, wherein the outer frame and the inner frameare secured against relative axial movement by at least one connector;unconstraining the plurality of ventricular anchors and the plurality ofatrial anchors while maintaining the valve body in theradially-contracted delivery configuration; and unconstraining the valvebody from the radially-contracted delivery configuration while theunconstrained atrial anchors are positioned within an atrium and whilethe unconstrained ventricular anchors are positioned within a ventricle,wherein unconstraining the valve body decreases a longitudinal distancebetween terminal ends of the unconstrained ventricular anchors andterminal ends of the unconstrained atrial anchors, such that nativemitral valve tissue is clamped between the ventricular anchors andatrial anchors.
 2. The method of claim 1, wherein the plurality ofventricular anchors includes a plurality of ventricular anchoring legs,each ventricular anchoring leg having a respective terminal end, andwherein unconstraining the plurality of ventricular anchors causes theterminal ends of the ventricular anchoring legs to deflect radiallyoutward relative to the outer frame.
 3. The method of claim 1, whereinthe plurality of atrial anchors includes a plurality of atrial anchoringarms, each atrial anchoring arm having a respective terminal end, andwherein unconstraining the plurality of atrial anchors causes theterminal ends of the atrial anchoring arms to deflect radially outwardrelative to the inner frame.
 4. The method of claim 1, wherein the outerframe and the inner frame expand radially outward when the valve body isunconstrained.
 5. The method of claim 1, wherein unconstraining thevalve body causes the plurality of ventricular anchors and the pluralityof atrial anchors to grasp tissue therebetween to secure the prostheticvalve to the native mitral valve.
 6. The method of claim 1, furthercomprising: prior to unconstraining the valve body, moving theunconstrained ventricular anchors so that they engage tissue on aventricular side of the native mitral valve.
 7. The method of claim 1,further comprising: prior to unconstraining the valve body, moving theunconstrained atrial anchors so that they engage tissue on an atrialside of the native mitral valve.
 8. The method of claim 1, wherein theplurality of ventricular anchors is unconstrained prior tounconstraining the plurality of atrial anchors.
 9. The method of claim1, wherein the plurality of atrial anchors is unconstrained prior tounconstraining the plurality of ventricular anchors.
 10. The method ofclaim 1, wherein the unconstrained ventricular anchors and theunconstrained atrial anchors enable motion of leaflets of the nativemitral valve in response to beating of the heart, prior tounconstraining the valve body.
 11. The method of claim 1, wherein theinner frame extends in an upstream direction beyond an upstream end ofthe outer frame.
 12. The method of claim 1, wherein the outer frame andthe inner frame are constrained in the contracted delivery configurationduring unconstraining of the plurality of ventricular anchors and theplurality of atrial anchors.
 13. The method of claim 1, whereinunconstraining the valve body shifts points of connection between theplurality of ventricular anchors and the outer frame radially outward.14. The method of claim 1, wherein unconstraining the valve body shiftspoints of connection between the plurality of atrial anchors and theinner frame radially outward.
 15. The method of claim 1, wherein theplurality of ventricular anchors and the plurality of atrial anchors areunconstrained in at least one of the atrium and the ventricle.
 16. Themethod of claim 1, wherein the at least one connector securing the outerframe and inner frame against relative axial movement comprises at leastone of: a mechanical connector extending between the outer frame and theinner frame, solder, or a weld.
 17. The method of claim 1, wherein theouter frame is formed at least partially of struts intersecting at aplurality of outer frame junctions, the ventricular anchors extendingfrom outer frame junctions that are spaced apart from an upstream end ofthe outer frame and a downstream end of the outer frame.
 18. A method ofimplanting a prosthetic valve within a native mitral valve, the methodcomprising: delivering the prosthetic valve into a heart chamber whilethe prosthetic valve is constrained in a contracted deliveryconfiguration, wherein the prosthetic valve includes an annular valvebody with a plurality of ventricular anchors and a plurality of atrialanchors attached thereto; unconstraining the plurality of ventricularanchors while maintaining the plurality of atrial anchors and the valvebody in the contracted delivery configuration; repositioning theunconstrained ventricular anchors prior to unconstraining the pluralityof atrial anchors such that at least one unconstrained ventricularanchor contacts tissue of the native mitral valve; unconstraining theplurality of atrial anchors while the at least one unconstrainedventricular anchor contacts the tissue of the native mitral valve andwhile the valve body is maintained in the contracted deliveryconfiguration; and unconstraining the valve body from the contracteddelivery configuration while the unconstrained atrial anchors arepositioned within an atrium and while the unconstrained ventricularanchors are positioned within a ventricle, wherein unconstraining thevalve body decreases a longitudinal distance between terminal ends ofthe unconstrained ventricular anchors and terminal ends of theunconstrained atrial anchors, such that native mitral valve tissue isclamped between the ventricular anchors and atrial anchors.
 19. Themethod of claim 18, wherein repositioning the unconstrained ventricularanchors comprises: moving the unconstrained ventricular anchors in anupstream direction until the at least one unconstrained ventricularanchor contacts a ventricular-facing side of a leaflet of the nativemitral valve.
 20. The method of claim 18, wherein the valve bodycomprises: an annular outer frame; an inner frame situated at leastpartially within the outer frame; and at least one connector configuredto secure the outer frame and the inner frame against relative axialmovement, wherein the plurality of ventricular anchors extend from theouter frame and the plurality of atrial anchors extend from the innerframe.
 21. A method of implanting a prosthetic valve within a nativemitral valve, the method comprising: delivering the prosthetic valveinto a heart chamber while the prosthetic valve is constrained in acontracted delivery configuration, wherein the prosthetic valve includesan annular valve body with a plurality of ventricular anchors and aplurality of atrial anchors attached thereto, the valve body comprising:an annular outer frame, and an inner frame situated at least partiallywithin the outer frame, wherein the plurality of ventricular anchorsextend from the outer frame and the plurality of atrial anchors extendfrom the inner frame, and wherein the plurality of ventricular anchorsare configured to be substantially flush with the inner frame when theplurality of ventricular anchors is in the contracted deliveryconfiguration; unconstraining the plurality of ventricular anchors andthe plurality of atrial anchors while maintaining the valve body in thecontracted delivery configuration; and unconstraining the valve bodyfrom the contracted delivery configuration while the unconstrainedatrial anchors are positioned within an atrium and while theunconstrained ventricular anchors are positioned within a ventricle.